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Alzheimer Disease ×
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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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244 Search results.

Eligibility Alzheimer's Disease NCT01450891

- 11/5/20 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Health Technology Assessment of Diagnostic Approaches in Alzheimer's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01450891

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - Magnetic resonance imaging investigation (3T‐MRT‐Untersuchung)

- 10/30/20 - 1 form, 4 itemgroups, 11 items, 1 language
Itemgroups: Administrative Data, Information about MRI, Performance of first MRI, Performance of second MRI
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 form contains information about the MRI investigation.

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - MRI - Contraindication form (MRT-Kontraindikationsbogen)

- 10/30/20 - 1 form, 2 itemgroups, 15 items, 1 language
Itemgroups: Administrative Data, MRI- Contraindications
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 form contains information about contraindication for a MRI scan.

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - PET Investigation - In- and exclusion criteria

- 10/30/20 - 1 form, 5 itemgroups, 23 items, 1 language
Itemgroups: Administrative Data, PET‐Screening, PET-screening: Inclusion criteria, PET-screening: Exclusion criteria, Direct address of the test person
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 information about the PET investigation. It has to be filled in before PET study inclusion or before the PET follow-up examination.

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - PET Investigation

- 10/30/20 - 1 form, 3 itemgroups, 61 items, 1 language
Itemgroups: Administrative Data, FBB-PET-Examination, FDG-PET
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 information about the PET investigation. The PET investigation form is for patients eligible for the PET sub-study of DELCODE only. Two PET investigations are to be conducted: a baseline investigation once eligible and a follow-up investigation 24 months after the baseline PET.

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - Food

- 10/28/20 - 1 form, 2 itemgroups, 17 items, 1 language
Itemgroups: Administrative Data, Food
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 food form. This form has to be filled out at baseline and all follow-ups.

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - Neuropsychological testing (Neuropsychologische Testung)

- 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.

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - Sample collection (blood, urin, liquor) (Probenentnahme)

- 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.

Measurement Instrument Database for the Social Science (MIDSS) - Caregiver Burden Scale

- 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

Eligibility Late Onset Alzheimer Disease NCT01222351

- 6/15/20 - 1 form, 2 itemgroups, 11 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Measuring Brain Amyloid Plaque Load in Older Adults Using BAY 94-9172; ODM derived from: https://clinicaltrials.gov/show/NCT01222351

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - 8‐Meter‐Walking‐Test (8MWT), 9‐hole peg Test (9HPT)

- 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.

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - Neuropsychiatric interview (NPI-Q) (Neuropsychiatrisches Intervies (NPI‐Q))

- 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.