Keywords
Alzheimer Disease ×
Show more Keywords
Table of contents
  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
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- 8/31/20 - 1 form, 17 itemgroups, 72 items, 1 language
Itemgroups: Administrative Data, Neuropsychological testing, Orienting sensory evaluation, Verbal fluency, WMS‐IV - logical memory 1, Symbol Digit Modalities (SDMT), Incidental learning, WMS-R, Watch drawing, Trail Making Test, WMS‐IV - logical memory II, ADAS – Cog13, Free and Cued Selective Reminding Test with Immediate Revall (FCSRT‐IR), Face Name Test (Computer Test), Arrow test (Computertest), Multiple vocabulary intelligence test, Comments and remarks
DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the Neuropsychological testing form. It has to be filled in for baseline and for all follow-ups. This form contains several questionnaires: Verbal Fluency, Wechsler Memory Scale (WMS-IV, WMS-R), Symbol Digit Modalitites, Incidental learning, Watch drawing, Trail Making Test, Alzheimer’s Disease Assessment Scale – Cognitive (ADAS-Cog13), Free and Cued Selective Reminding Test with immediate Recall (FCSRT-IR), Face Name Test, Arrow test and MWT-B. Due to potential copyright on the questionnaires ADAS-Cog13 and FCSRT-IR included in the DZNE DELCODE protocol, these quetionnaire will only be included as (sub-)scores/text result items in this version of the DELCODE forms. The respective score items will have a comment in their descriptions about this to distinguish them from score items that were already defined like that by DZNE.
- 8/28/20 - 1 form, 10 itemgroups, 68 items, 1 language
Itemgroups: Administrative Data, Blood sample, Specimen Collection - Blood, Registration of blood samples , Urine sample, Results of urine stick, Registration of urine samples, Liquor collection, Registration of liquor samples, Sample collection according to SOP
DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the sample collection form. It contains information about blood sample, urin collection and liquor sample. It has to be filled in for baseline and for all follow-ups.
- 6/30/20 - 1 form, 16 itemgroups, 60 items, 1 language
Itemgroups: Caregiver Burden Scale, Transportation, Housekeeping, Cooking, Shopping, Decision Making, Financial Record Keeping, Walking, Making House Repairs, Farming/Yard Work, Administering Medication, Dressing, Bathing, Eating, Toileting, Leaving Patient Unattended
Macera, C.A., Eaker, E.D., Jannarone, R.J., Davis, D.R., Stoskopf, C.H.. (1993). Caregiver Burden Scale. Measurement Instrument Database for the Social Science. Retrieved 30/06/2020, from www.midss.ie Key references: Macera, C.A., Eaker, E.D., Jannarone, R.J., Davis, D.R., Stoskopf, C.H., 1993. A Measure of Perceived Burden among Caregivers. Evaluation & the Health Professions 16 (2), 204–211. Primary use / Purpose: To assess perceived burden among people caring for others with disabilities. Background: This caregiver burden scale was developed to assess perceived burden among caregivers of family members with dementia. While everyone who is a caregiver will assist with tasks for their family member with dementia, our previous research found that burden was more than just the number or type of tasks for which the patient required assistance. By obtaining a measure of the caregivers' perceived burden associated with each of 15 possible tasks, we were able to narrow down the source of stress in a way that could lead to effective interventions. Psychometrics: Internal consistency of the scale: 0.87 Correlation with depressive symptoms (CES-D): 0.38 (p<0.001). Scoring Three domains are measured from this scale. The first one, defined as patient needs, is a sum of the 15 items providing a range of 0-15. The second one, defined as caregiver tasks, is the sum of the tasks for which the caregiver provided assistance. The range could be 0-15, but cannot be higher than the sum of the patient needs. The third domain, caregiver burden, is a sum of the items for which the patient needed assistance AND the caregiver provided assistance AND the caregiver reported that providing this assistance was stressful. The possible range was 0-15 but could not be higher than the number of caregiver tasks. Digital Object Identifier (DOI): http://dx.doi.org/10.13072/midss.389
- 4/22/20 - 1 form, 3 itemgroups, 25 items, 1 language
Itemgroups: Administrative Data, 8‐Meter‐Walking‐Test (8MWT), 9‐hole peg Test (9HPT)
DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the 8‐Meter‐Walking‐Test (8MWT) and the 9‐hole peg Test (9HPT). It has to be filled in for baseline and for all follow-ups.
- 4/22/20 - 1 form, 2 itemgroups, 6 items, 1 language
Itemgroups: Administrative Data, Neuropsychiatric Interview (NPI-Q)
DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the Neuropsychiatric interview (NPI-Q). It has to be filled in for baseline and for all follow-ups. Due to potential copyright on this questionnaire included in the DZNE DELCODE protocol, the NPI-Q will only be included as text result items in this version of the DELCODE forms. The respective score items will have a comment in their descriptions about this to distinguish them from score items that were already defined like that by DZNE. For more information see: DOI:10.1017/S1041610210001237 or npitest.net.
- 4/22/20 - 1 form, 3 itemgroups, 28 items, 1 language
Itemgroups: Administrative Data, Smelling ability, Smell history
DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the Smelling ability test. It has to be filled in for baseline and for all follow-ups.
- 4/20/20 - 1 form, 4 itemgroups, 18 items, 2 languages
Itemgroups: Administrative Data, Clinical Dementia Rating (CDR), modified, Informant, Clinical Dementia Rating (CDR), modified, Subject, Clinical Dementia Rating (CDR), modified, summary
DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the Clinical Dementia Rating (CDR) form. It has to be filled in for baseline and for all follow-ups. Due to a necessary license agreement for use of the CDR, it will only be included as subscore/result items in this version of DELCODE forms. The respective score items will have a comment in their descriptions about this to distinguish them from score items that were already defined like that by DZNE. For more information see: https://otm.wustl.edu/for-industry/tools/cdr-licensing/
- 4/18/20 - 1 form, 2 itemgroups, 12 items, 2 languages
Itemgroups: Administrative Data, Minimal Mental State Examination (MMSE)
DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the results of the Minimal Mental State Examination (MMSE) form. It has to be filled in for Baseline and all Follow-ups. For more information see: Folstein MF, Folstein SE and McHugh PR. Mini-Mental State: A practical method for grading the state of patients for the clinician, Journal of Psychiatric Research 1975; 12: 189-198
- 4/14/20 - 1 form, 3 itemgroups, 21 items, 1 language
Itemgroups: Administrative Data, Geriatric Depression Scale (GDS), Geriatric Anxiety Inventory – Short Form (GAI‐SF)
DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the Geriatric Depression Scale (GDS) and the Geriatric Anxiety Inventory – Short Form (GAI‐SF). It has to be filled in for Baseline and for all Follow-ups. For use of the questionnaire GDS no licence is required. For more information to the GDS see Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982-83;17(1):37-49. Due to potential copyright on the questionnaire GAI-SF included in the DZNE DELCODE protocol, GAI-SF will only be included as text result item in this version of the DELCODE forms (at least until permission to publish is received from the original authors or becomes clear upon further research). The respective score items will have a comment in their descriptions about this to distinguish them from score items that were already defined like that by DZNE. For more information to GAI-SF see: Pachana, N., Byrne, G., Siddle, H., Koloski, N., Harley, E., & Arnold, E. (2007). Development and validation of the Geriatric Anxiety Inventory. International Psychogeriatrics, 19, 103-114. doi: 10.1017/S1041610206003504. Rozzini, L., Chilovi, B., Peli, M., Conti, M., Rozzini, R., Trabucchi, M., Padovani, A. (2009). Anxiety symptoms in mild cognitive impairment. International Journal of Geriatric Psychiatry, 24, 300-305. doi: 10.1002/gps.2106.
- 4/9/20 - 1 form, 2 itemgroups, 8 items, 1 language
Itemgroups: Administrative Data, Medical history cognition (supplementary information)
DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the medical history cognition 3 form. It has to be filled in for Baseline and all Follow-ups. Note: The Form "Medical history cognition 1" has to be filled in with subject whereas the form "Medical history cognition 2" with the informant and the form "Medical history cognition 3" by the physician/ medical person.
- 4/9/20 - 1 form, 3 itemgroups, 44 items, 1 language
Itemgroups: Administrative Data, Medical history cognition (open initial question to subject), Medical history cognition (structured interview to cognitive disorders)
DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the medical history cognition 1 form. It has to be filled in for Baseline and all Follow-ups. Note: The Form "Medical history cognition 1" has to be filled in with subject whereas the form "Medical history cognition 2" with the informant and the form "Medical history cognition 3" by the physician/ medical person.