ID

44645

Description

Treatment of Behavioral Symptoms in Alzheimer's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00009217

Link

https://clinicaltrials.gov/show/NCT00009217

Keywords

Versions (2)
  1. 1/29/16 1/29/16 -
  2. 9/27/21 9/27/21 -
Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Alzheimer's Disease NCT00009217

English

Eligibility Alzheimer's Disease NCT00009217

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
meets dsm-iv criteria for dementia either sex, age 50-95 years
Description

study participants

Data type

boolean

Alias
UMLS CUI [1,1]
C0236962
UMLS CUI [1,2]
C0497327
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
meets nincds-adrda criteria for probable alzheimer's disease
Description

nincds-adrda criteria for alzheimer's disease

Data type

boolean

Alias
UMLS CUI [1]
C2828081
meets folstein mini-mental state exam score of 5-26, inclusive
Description

folstein mini-mental state examination

Data type

boolean

Alias
UMLS CUI [1]
C0451306
intellectual impairment reported for at least six months
Description

intellectual impairment

Data type

boolean

Alias
UMLS CUI [1]
C0683322
availability of family member who has had direct contact with the patient for an average of at least once every week during the three months prior to study entry
Description

familiy member

Data type

boolean

Alias
UMLS CUI [1,1]
C0086282
UMLS CUI [1,2]
C0332158
has current symptoms of psychosis or agitation. criteria for "psychosis" requires the presence of delusions and/or hallucinations identified by the columbia university scale for psychopathology in alzheimer's disease (cuspad) and a minimum brief psychiatric rating scale (bprs) psychosis factor score of at least 4 (moderate severity) on one of the following two items: these two items comprise the psychosis factor, excluding the item for conceptual disorganization. agitation is defined as a score of greater than 3 (present at least 10 days per month) on one or more of the cerad behavioral rating scale for dementia items for agitation, purposeless wandering, verbal aggression or physical aggression.
Description

Psychosis or agitation

Data type

boolean

Alias
UMLS CUI [1]
C0011253
UMLS CUI [2]
C0018524
UMLS CUI [3]
C0029941
UMLS CUI [4]
C0085631
UMLS CUI [5]
C3887612
UMLS CUI [6]
C0424322
UMLS CUI [7]
C0424323
free of psychotropic medication for at least two weeks prior to study entry, or able to tolerate medication washout for this period.
Description

psychotropic medication

Data type

boolean

Alias
UMLS CUI [1]
C0033978
informed consent by patient and family member, as per irb procedures at new york state psychiatric institute.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
acute unstable medical condition, delirium, alcohol or substance abuse or dependence within the past 1
Description

Participant status

Data type

boolean

Alias
UMLS CUI [1]
C0184773
UMLS CUI [2]
C0011206
UMLS CUI [3]
C0038586
clinical evidence of stroke, other dementias including vascular or lewy body or frontotemporal dementia, multiple sclerosis, parkinson's disease, huntington's disease, tardive dyskinesia
Description

Neurological status

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0854731
UMLS CUI [3]
C0752347
UMLS CUI [4]
C0338451
UMLS CUI [5]
C0026769
UMLS CUI [6]
C0030567
UMLS CUI [7]
C0020179
UMLS CUI [8]
C0686347
diagnosis of a psychotic disorder antedating the onset of dementia
Description

psychotic disorder

Data type

boolean

Alias
UMLS CUI [1]
C0033975
antipsychotic medication usage during 4 weeks prior to study entry
Description

antipsychotic medication

Data type

boolean

Alias
UMLS CUI [1]
C0748066
contraindication to the use of haloperidol
Description

Haloperidol

Data type

boolean

Alias
UMLS CUI [1,1]
C0018546
UMLS CUI [1,2]
C1301624
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Similar models

Eligibility Alzheimer's Disease NCT00009217

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
study participants
Item
meets dsm-iv criteria for dementia either sex, age 50-95 years
boolean
C0236962 (UMLS CUI [1,1])
C0497327 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
nincds-adrda criteria for alzheimer's disease
Item
meets nincds-adrda criteria for probable alzheimer's disease
boolean
C2828081 (UMLS CUI [1])
folstein mini-mental state examination
Item
meets folstein mini-mental state exam score of 5-26, inclusive
boolean
C0451306 (UMLS CUI [1])
intellectual impairment
Item
intellectual impairment reported for at least six months
boolean
C0683322 (UMLS CUI [1])
familiy member
Item
availability of family member who has had direct contact with the patient for an average of at least once every week during the three months prior to study entry
boolean
C0086282 (UMLS CUI [1,1])
C0332158 (UMLS CUI [1,2])
Psychosis or agitation
Item
has current symptoms of psychosis or agitation. criteria for "psychosis" requires the presence of delusions and/or hallucinations identified by the columbia university scale for psychopathology in alzheimer's disease (cuspad) and a minimum brief psychiatric rating scale (bprs) psychosis factor score of at least 4 (moderate severity) on one of the following two items: these two items comprise the psychosis factor, excluding the item for conceptual disorganization. agitation is defined as a score of greater than 3 (present at least 10 days per month) on one or more of the cerad behavioral rating scale for dementia items for agitation, purposeless wandering, verbal aggression or physical aggression.
boolean
C0011253 (UMLS CUI [1])
C0018524 (UMLS CUI [2])
C0029941 (UMLS CUI [3])
C0085631 (UMLS CUI [4])
C3887612 (UMLS CUI [5])
C0424322 (UMLS CUI [6])
C0424323 (UMLS CUI [7])
psychotropic medication
Item
free of psychotropic medication for at least two weeks prior to study entry, or able to tolerate medication washout for this period.
boolean
C0033978 (UMLS CUI [1])
informed consent
Item
informed consent by patient and family member, as per irb procedures at new york state psychiatric institute.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Participant status
Item
acute unstable medical condition, delirium, alcohol or substance abuse or dependence within the past 1
boolean
C0184773 (UMLS CUI [1])
C0011206 (UMLS CUI [2])
C0038586 (UMLS CUI [3])
Neurological status
Item
clinical evidence of stroke, other dementias including vascular or lewy body or frontotemporal dementia, multiple sclerosis, parkinson's disease, huntington's disease, tardive dyskinesia
boolean
C0038454 (UMLS CUI [1])
C0854731 (UMLS CUI [2])
C0752347 (UMLS CUI [3])
C0338451 (UMLS CUI [4])
C0026769 (UMLS CUI [5])
C0030567 (UMLS CUI [6])
C0020179 (UMLS CUI [7])
C0686347 (UMLS CUI [8])
psychotic disorder
Item
diagnosis of a psychotic disorder antedating the onset of dementia
boolean
C0033975 (UMLS CUI [1])
antipsychotic medication
Item
antipsychotic medication usage during 4 weeks prior to study entry
boolean
C0748066 (UMLS CUI [1])
Haloperidol
Item
contraindication to the use of haloperidol
boolean
C0018546 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
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