ID

39368

Description

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

Keywords

Versions (1)
  1. 1/2/20 1/2/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 2, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Healthy Elderly Volunteers NCT01795339

English

Eligibility Healthy Elderly Volunteers NCT01795339

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
part 1: healthy elderly male and female (of non-childbearing potential) subjects.
Description

Well male elder | Well female elder | Gender Childbearing Potential Absent

Data type

boolean

Alias
UMLS CUI [1]
C0686754
UMLS CUI [2]
C0686755
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C3831118
UMLS CUI [3,3]
C0332197
part 2: male and non-fertile female ad patients.
Description

Gender | Gender Childbearing Potential Absent | Alzheimer's Disease

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C3831118
UMLS CUI [2,3]
C0332197
UMLS CUI [3]
C0002395
body mass index (bmi) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
Description

Body mass index | Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0005910
part 2: clinical diagnosis of probable ad according to the nincds-adrda criteria.
Description

Alzheimer's Disease Probable NINCDS-ADRDA Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0002395
UMLS CUI [1,2]
C0033204
UMLS CUI [1,3]
C2828081
part 2: manifestation of ad symptoms at least 6 months before randomization.
Description

Symptoms Alzheimer's Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0002395
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
part 1: history or presence of psychiatric disease/condition, gi, renal, hepatic, cardiovascular, psychiatric, or retinal diseases or disorders.
Description

Mental disorders | Mental condition | Gastrointestinal Diseases | Kidney Diseases | Liver diseases | Cardiovascular Diseases | Retinal Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C3840291
UMLS CUI [3]
C0017178
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0023895
UMLS CUI [6]
C0007222
UMLS CUI [7]
C0035309
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.
Description

Disease Affecting Central Nervous System | Exception Alzheimer's Disease | Dementia | Nervous system disorder | Major psychiatric illness

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C3714787
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0002395
UMLS CUI [3]
C0497327
UMLS CUI [4]
C0027765
UMLS CUI [5]
C4534351
history of use of antipsychotic drugs , or chronic use of antidepressant or anxiolytic drugs.
Description

Antipsychotic Agents | Antidepressive Agents chronic | Anti-Anxiety Agents chronic

Data type

boolean

Alias
UMLS CUI [1]
C0040615
UMLS CUI [2,1]
C0003289
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C0040616
UMLS CUI [3,2]
C0205191
frequent use (more than 2 days per week during the last 12 weeks) of tobacco or other nicotine products.
Description

Tobacco use Frequent | Use of Nicotine product Frequent

Data type

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0332183
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0028040
UMLS CUI [2,3]
C0332183
history of neurological disease, including seizures, recent memory impairment, or clinically significant head injury.
Description

Nervous system disorder | Seizures | Memory impairment Recent | Craniocerebral Trauma

Data type

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0036572
UMLS CUI [3,1]
C0233794
UMLS CUI [3,2]
C0332185
UMLS CUI [4]
C0018674
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Similar models

Eligibility Healthy Elderly Volunteers NCT01795339

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
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])
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
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])
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])
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