ID

43981

Description

Evaluation of 3APS in Patients With Mild to Moderate Alzheimer’s Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00088673

Link

https://clinicaltrials.gov/show/NCT00088673

Keywords

  1. 4/4/16 4/4/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility Alzheimer Disease NCT00088673

Eligibility Alzheimer Disease NCT00088673

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients may be included in this study if they meet all of the following criteria:
Description

Inclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C1512693
male or female (age 50 years and older): female must be of non-childbearing potential (i.e. surgically sterilized or at least 2 years post-menopausal).
Description

gender; Contraception status

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0086287
diagnosis of probable alzheimer’s disease based on the national institute of neurological and communicative disorders and stroke/alzheimer’s disease and related disorders association (nincds-adrda criteria).
Description

alzheimers disease; neurological disease; stroke

Data type

boolean

Alias
UMLS CUI [1]
C0002395
UMLS CUI [2]
C0027765
UMLS CUI [3]
C0038454
severity of dementia of mild to moderate degree as assessed by the mini mental state examination (mmse) performed at the screening visit.
Description

dementia; mini mental state examination; screening visit

Data type

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2]
C0451306
UMLS CUI [3]
C2097637
patient must be living in the community with a reliable caregiver. participant living in an assisted living facility may be included if study medication intake is supervised and participant has a reliable caregiver.
Description

caregiver

Data type

boolean

Alias
UMLS CUI [1]
C0085537
potential participant must be treated with conventional alzheimer’s disease therapies and must be on stable dose for at least 4 months prior to the screening visit and during the entire study period.
Description

therapy Alzheimer's Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0002395
fluency in english, french or spanish (oral and written).
Description

language

Data type

boolean

Alias
UMLS CUI [1]
C1145677
signed informed consent from potential participant or legal representative and caregiver.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients will not be eligible to participate in the study if they meet any of the following criteria:
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
potential participant with any other cause of dementia.
Description

dementia

Data type

boolean

Alias
UMLS CUI [1]
C0497327
life expectancy less than 2 years.
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
potential participant with a clinically significant and/or uncontrolled condition or other significant medical disease.
Description

concomitant disease

Data type

boolean

Alias
UMLS CUI [1]
C0243087
use of an investigational drug within 30 days prior to the screening visit or during the entire study.
Description

investigational drug; screening visit

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2097637
previous use of 3aps.
Description

ID.14

Data type

boolean

patient recruitment is done by participating centers.
Description

patient recruitment

Data type

boolean

Alias
UMLS CUI [1]
C0242800

Similar models

Eligibility Alzheimer Disease NCT00088673

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion Criteria
Item
patients may be included in this study if they meet all of the following criteria:
boolean
C1512693 (UMLS CUI [1])
gender; Contraception status
Item
male or female (age 50 years and older): female must be of non-childbearing potential (i.e. surgically sterilized or at least 2 years post-menopausal).
boolean
C0079399 (UMLS CUI [1])
C0086287 (UMLS CUI [2])
alzheimers disease; neurological disease; stroke
Item
diagnosis of probable alzheimer’s disease based on the national institute of neurological and communicative disorders and stroke/alzheimer’s disease and related disorders association (nincds-adrda criteria).
boolean
C0002395 (UMLS CUI [1])
C0027765 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
dementia; mini mental state examination; screening visit
Item
severity of dementia of mild to moderate degree as assessed by the mini mental state examination (mmse) performed at the screening visit.
boolean
C0497327 (UMLS CUI [1])
C0451306 (UMLS CUI [2])
C2097637 (UMLS CUI [3])
caregiver
Item
patient must be living in the community with a reliable caregiver. participant living in an assisted living facility may be included if study medication intake is supervised and participant has a reliable caregiver.
boolean
C0085537 (UMLS CUI [1])
therapy Alzheimer's Disease
Item
potential participant must be treated with conventional alzheimer’s disease therapies and must be on stable dose for at least 4 months prior to the screening visit and during the entire study period.
boolean
C0087111 (UMLS CUI [1,1])
C0002395 (UMLS CUI [1,2])
language
Item
fluency in english, french or spanish (oral and written).
boolean
C1145677 (UMLS CUI [1])
informed consent
Item
signed informed consent from potential participant or legal representative and caregiver.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria
Item
patients will not be eligible to participate in the study if they meet any of the following criteria:
boolean
C0680251 (UMLS CUI [1])
dementia
Item
potential participant with any other cause of dementia.
boolean
C0497327 (UMLS CUI [1])
life expectancy
Item
life expectancy less than 2 years.
boolean
C0023671 (UMLS CUI [1])
concomitant disease
Item
potential participant with a clinically significant and/or uncontrolled condition or other significant medical disease.
boolean
C0243087 (UMLS CUI [1])
investigational drug; screening visit
Item
use of an investigational drug within 30 days prior to the screening visit or during the entire study.
boolean
C0013230 (UMLS CUI [1])
C2097637 (UMLS CUI [2])
ID.14
Item
previous use of 3aps.
boolean
patient recruitment
Item
patient recruitment is done by participating centers.
boolean
C0242800 (UMLS CUI [1])

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