Informações:
Falhas:
ID
39368
Descrição
A Two-part Multiple Dose Study to Assess the Safety and Effects of AZD3293 in Healthy Elderly and Alzheimer's Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01795339
Link
https://clinicaltrials.gov/show/NCT01795339
Palavras-chave
Versões (1)
- 02/01/2020 02/01/2020 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
2 de janeiro de 2020
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Healthy Elderly Volunteers NCT01795339
Eligibility Healthy Elderly Volunteers NCT01795339
- StudyEvent: Eligibility
Similar models
Eligibility Healthy Elderly Volunteers NCT01795339
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Well male elder | Well female elder | Gender Childbearing Potential Absent
Item
part 1: healthy elderly male and female (of non-childbearing potential) subjects.
boolean
C0686754 (UMLS CUI [1])
C0686755 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C3831118 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0686755 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C3831118 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Gender | Gender Childbearing Potential Absent | Alzheimer's Disease
Item
part 2: male and non-fertile female ad patients.
boolean
C0079399 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C3831118 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0002395 (UMLS CUI [3])
C0079399 (UMLS CUI [2,1])
C3831118 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0002395 (UMLS CUI [3])
Body mass index | Body Weight
Item
body mass index (bmi) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
C0005910 (UMLS CUI [2])
Alzheimer's Disease Probable NINCDS-ADRDA Criteria
Item
part 2: clinical diagnosis of probable ad according to the nincds-adrda criteria.
boolean
C0002395 (UMLS CUI [1,1])
C0033204 (UMLS CUI [1,2])
C2828081 (UMLS CUI [1,3])
C0033204 (UMLS CUI [1,2])
C2828081 (UMLS CUI [1,3])
Symptoms Alzheimer's Disease
Item
part 2: manifestation of ad symptoms at least 6 months before randomization.
boolean
C1457887 (UMLS CUI [1,1])
C0002395 (UMLS CUI [1,2])
C0002395 (UMLS CUI [1,2])
Mental disorders | Mental condition | Gastrointestinal Diseases | Kidney Diseases | Liver diseases | Cardiovascular Diseases | Retinal Diseases
Item
part 1: history or presence of psychiatric disease/condition, gi, renal, hepatic, cardiovascular, psychiatric, or retinal diseases or disorders.
boolean
C0004936 (UMLS CUI [1])
C3840291 (UMLS CUI [2])
C0017178 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0007222 (UMLS CUI [6])
C0035309 (UMLS CUI [7])
C3840291 (UMLS CUI [2])
C0017178 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0007222 (UMLS CUI [6])
C0035309 (UMLS CUI [7])
Disease Affecting Central Nervous System | Exception Alzheimer's Disease | Dementia | Nervous system disorder | Major psychiatric illness
Item
part 2: significant disease affecting the cns other than alzheimer's disease, including but not limited to other dementias, other significant neurological or major psychiatric disease.
boolean
C0012634 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C3714787 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0002395 (UMLS CUI [2,2])
C0497327 (UMLS CUI [3])
C0027765 (UMLS CUI [4])
C4534351 (UMLS CUI [5])
C0392760 (UMLS CUI [1,2])
C3714787 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0002395 (UMLS CUI [2,2])
C0497327 (UMLS CUI [3])
C0027765 (UMLS CUI [4])
C4534351 (UMLS CUI [5])
Antipsychotic Agents | Antidepressive Agents chronic | Anti-Anxiety Agents chronic
Item
history of use of antipsychotic drugs , or chronic use of antidepressant or anxiolytic drugs.
boolean
C0040615 (UMLS CUI [1])
C0003289 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0040616 (UMLS CUI [3,1])
C0205191 (UMLS CUI [3,2])
C0003289 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0040616 (UMLS CUI [3,1])
C0205191 (UMLS CUI [3,2])
Tobacco use Frequent | Use of Nicotine product Frequent
Item
frequent use (more than 2 days per week during the last 12 weeks) of tobacco or other nicotine products.
boolean
C0543414 (UMLS CUI [1,1])
C0332183 (UMLS CUI [1,2])
C1524063 (UMLS CUI [2,1])
C0028040 (UMLS CUI [2,2])
C0332183 (UMLS CUI [2,3])
C0332183 (UMLS CUI [1,2])
C1524063 (UMLS CUI [2,1])
C0028040 (UMLS CUI [2,2])
C0332183 (UMLS CUI [2,3])
Nervous system disorder | Seizures | Memory impairment Recent | Craniocerebral Trauma
Item
history of neurological disease, including seizures, recent memory impairment, or clinically significant head injury.
boolean
C0027765 (UMLS CUI [1])
C0036572 (UMLS CUI [2])
C0233794 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
C0018674 (UMLS CUI [4])
C0036572 (UMLS CUI [2])
C0233794 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
C0018674 (UMLS CUI [4])