ID

16982

Description

Apathy Associated With Alzheimer's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00254033

Link

https://clinicaltrials.gov/show/NCT00254033

Keywords

Versions (1)
  1. 8/17/16 8/17/16 -
Uploaded on

August 17, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Dementia NCT00254033

English

Eligibility Dementia NCT00254033

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Dementia NCT00254033
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age > 55 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
meet dsm-iv criteria for primary degenerative dementia
Description

Primary degenerative dementia

Data type

boolean

Alias
UMLS CUI [1]
C3714594
meet nincds-arda criteria for probable alzheimer's disease of at least one year's duration
Description

Alzheimer's Disease Probable Duration | NINCDS-ADRDA Criteria for Alzheimer's Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0002395
UMLS CUI [1,2]
C0033204
UMLS CUI [1,3]
C0449238
UMLS CUI [2]
C2828081
mild to moderate cognitive impairment (global deterioration scale gds <6, mini-mental state examination >10
Description

Cognitive impairment, mild to moderate | Global deterioration scale finding for assessment of primary degenerative dementia | Mini-mental state examination

Data type

boolean

Alias
UMLS CUI [1]
C3554028
UMLS CUI [2]
C1319815
UMLS CUI [3]
C0451306
on a stable dose of a cholinesterase inhibitor for at least 3 months
Description

Cholinesterase Inhibitor Dosage Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0008425
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
apathetic group only: neuropsychiatric inventory (npi) apathy subscale score >=2
Description

Apathy Group | NPI - Apathy/Indifference Score

Data type

boolean

Alias
UMLS CUI [1,1]
C0085632
UMLS CUI [1,2]
C0441833
UMLS CUI [2]
C3828762
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
abnormal biochemical screening: blood cell count, vitamin b12, thyroid function tests, and syphilis screening tests
Description

Biochemical screening test Abnormal | Blood Cell Count | VITAMIN B12 MEASUREMENT | Thyroid Function Tests | Syphilis Screening test

Data type

boolean

Alias
UMLS CUI [1,1]
C1278201
UMLS CUI [1,2]
C0205161
UMLS CUI [2]
C0005771
UMLS CUI [3]
C0202252
UMLS CUI [4]
C0040130
UMLS CUI [5,1]
C0039128
UMLS CUI [5,2]
C0871311
significant medical illness or other medical/neurological conditions which diminish cognitive function
Description

Other medical condition Limiting Cognitive functions

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0392335
evidence of seizure disorder
Description

Epilepsy Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C0014544
UMLS CUI [1,2]
C0332120
an hachinski ischemic score >3 indicating vascular dementia
Description

Hachinski ischemia score suggest Dementia, Vascular

Data type

boolean

Alias
UMLS CUI [1,1]
C0475492
UMLS CUI [1,2]
C1705535
UMLS CUI [1,3]
C0011269
a brain computed tomographic (ct) scan revealing focal lesions, or inconsistent with ad
Description

ct brain scan Revealing Lesion Focal | ct brain scan Inconsistent Alzheimer's Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0412585
UMLS CUI [1,2]
C0443289
UMLS CUI [1,3]
C0221198
UMLS CUI [1,4]
C0205234
UMLS CUI [2,1]
C0412585
UMLS CUI [2,2]
C0442809
UMLS CUI [2,3]
C0002395
electrocardiographic, laboratory or physical evidence of significant cardiovascular disease
Description

Cardiovascular Diseases Significant Evidence of | Electrocardiography | Laboratory Procedures | Physical Examination

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0332120
UMLS CUI [2]
C1623258
UMLS CUI [3]
C0022885
UMLS CUI [4]
C0031809
presence of premorbid or current psychiatric diagnosis including: major depression, schizophrenia, psychotic symptoms of a severity likely to provoke violent or dangerous behaviour (i.e., command hallucinations to harm people or persecutory delusions that provoke violent reactions)
Description

Diagnosis, Psychiatric | Psychiatric Diagnosis Premorbid estimate | Major Depressive Disorder | Schizophrenia | Psychotic symptom Severe | Physical aggression | Command hallucination | Delusion of persecution

Data type

boolean

Alias
UMLS CUI [1]
C0376338
UMLS CUI [2,1]
C0376338
UMLS CUI [2,2]
C4034407
UMLS CUI [3]
C1269683
UMLS CUI [4]
C0036341
UMLS CUI [5,1]
C0871189
UMLS CUI [5,2]
C0205082
UMLS CUI [6]
C0424323
UMLS CUI [7]
C0233781
UMLS CUI [8]
C1704268
current or past psychoactive substance abuse or dependence (including alcohol, excluding nicotine)
Description

Psychoactive substance abuse | Drug Dependence | Alcohol abuse | Nicotine abuse

Data type

boolean

Alias
UMLS CUI [1]
C0033880
UMLS CUI [2]
C1510472
UMLS CUI [3]
C0085762
UMLS CUI [4]
C2363943
contraindications to receiving dextroamphetamine or methylphenidate
Description

Medical contraindication Dextroamphetamine | Medical contraindication Methylphenidate

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0011812
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0025810
have had administration of a depot neuroleptic injection within one treatment cycle of the first visit
Description

Antipsychotic Agents Depot Preparations Injection

Data type

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0086129
UMLS CUI [1,3]
C1828121
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Similar models

Eligibility Dementia NCT00254033

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Dementia NCT00254033
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age > 55 years
boolean
C0001779 (UMLS CUI [1])
Primary degenerative dementia
Item
meet dsm-iv criteria for primary degenerative dementia
boolean
C3714594 (UMLS CUI [1])
Alzheimer's Disease Probable Duration | NINCDS-ADRDA Criteria for Alzheimer's Disease
Item
meet nincds-arda criteria for probable alzheimer's disease of at least one year's duration
boolean
C0002395 (UMLS CUI [1,1])
C0033204 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C2828081 (UMLS CUI [2])
Cognitive impairment, mild to moderate | Global deterioration scale finding for assessment of primary degenerative dementia | Mini-mental state examination
Item
mild to moderate cognitive impairment (global deterioration scale gds <6, mini-mental state examination >10
boolean
C3554028 (UMLS CUI [1])
C1319815 (UMLS CUI [2])
C0451306 (UMLS CUI [3])
Cholinesterase Inhibitor Dosage Stable
Item
on a stable dose of a cholinesterase inhibitor for at least 3 months
boolean
C0008425 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Apathy Group | NPI - Apathy/Indifference Score
Item
apathetic group only: neuropsychiatric inventory (npi) apathy subscale score >=2
boolean
C0085632 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])
C3828762 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Biochemical screening test Abnormal | Blood Cell Count | VITAMIN B12 MEASUREMENT | Thyroid Function Tests | Syphilis Screening test
Item
abnormal biochemical screening: blood cell count, vitamin b12, thyroid function tests, and syphilis screening tests
boolean
C1278201 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0005771 (UMLS CUI [2])
C0202252 (UMLS CUI [3])
C0040130 (UMLS CUI [4])
C0039128 (UMLS CUI [5,1])
C0871311 (UMLS CUI [5,2])
Other medical condition Limiting Cognitive functions
Item
significant medical illness or other medical/neurological conditions which diminish cognitive function
boolean
C3843040 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0392335 (UMLS CUI [1,3])
Epilepsy Evidence of
Item
evidence of seizure disorder
boolean
C0014544 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Hachinski ischemia score suggest Dementia, Vascular
Item
an hachinski ischemic score >3 indicating vascular dementia
boolean
C0475492 (UMLS CUI [1,1])
C1705535 (UMLS CUI [1,2])
C0011269 (UMLS CUI [1,3])
ct brain scan Revealing Lesion Focal | ct brain scan Inconsistent Alzheimer's Disease
Item
a brain computed tomographic (ct) scan revealing focal lesions, or inconsistent with ad
boolean
C0412585 (UMLS CUI [1,1])
C0443289 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
C0205234 (UMLS CUI [1,4])
C0412585 (UMLS CUI [2,1])
C0442809 (UMLS CUI [2,2])
C0002395 (UMLS CUI [2,3])
Cardiovascular Diseases Significant Evidence of | Electrocardiography | Laboratory Procedures | Physical Examination
Item
electrocardiographic, laboratory or physical evidence of significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,3])
C1623258 (UMLS CUI [2])
C0022885 (UMLS CUI [3])
C0031809 (UMLS CUI [4])
Diagnosis, Psychiatric | Psychiatric Diagnosis Premorbid estimate | Major Depressive Disorder | Schizophrenia | Psychotic symptom Severe | Physical aggression | Command hallucination | Delusion of persecution
Item
presence of premorbid or current psychiatric diagnosis including: major depression, schizophrenia, psychotic symptoms of a severity likely to provoke violent or dangerous behaviour (i.e., command hallucinations to harm people or persecutory delusions that provoke violent reactions)
boolean
C0376338 (UMLS CUI [1])
C0376338 (UMLS CUI [2,1])
C4034407 (UMLS CUI [2,2])
C1269683 (UMLS CUI [3])
C0036341 (UMLS CUI [4])
C0871189 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0424323 (UMLS CUI [6])
C0233781 (UMLS CUI [7])
C1704268 (UMLS CUI [8])
Psychoactive substance abuse | Drug Dependence | Alcohol abuse | Nicotine abuse
Item
current or past psychoactive substance abuse or dependence (including alcohol, excluding nicotine)
boolean
C0033880 (UMLS CUI [1])
C1510472 (UMLS CUI [2])
C0085762 (UMLS CUI [3])
C2363943 (UMLS CUI [4])
Medical contraindication Dextroamphetamine | Medical contraindication Methylphenidate
Item
contraindications to receiving dextroamphetamine or methylphenidate
boolean
C1301624 (UMLS CUI [1,1])
C0011812 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0025810 (UMLS CUI [2,2])
Antipsychotic Agents Depot Preparations Injection
Item
have had administration of a depot neuroleptic injection within one treatment cycle of the first visit
boolean
C0040615 (UMLS CUI [1,1])
C0086129 (UMLS CUI [1,2])
C1828121 (UMLS CUI [1,3])
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