Informações:
Falhas:
ID
43981
Descrição
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
Palavras-chave
Versões (2)
- 04/04/2016 04/04/2016 -
- 20/09/2021 20/09/2021 -
Transferido a
20 de setembro de 2021
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Alzheimer Disease NCT00088673
Eligibility Alzheimer Disease NCT00088673
- StudyEvent: Eligibility
Similar models
Eligibility Alzheimer Disease NCT00088673
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
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])
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])
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])
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])
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])