ID

43590

Descripción

Comparative Efficacy, Safety, and Tolerability of Rivastigmine 10 and 15 cm^2 Patch in Patients With Alzheimer's Disease (AD) Showing Cognitive Decline; ODM derived from: https://clinicaltrials.gov/show/NCT00506415

Link

https://clinicaltrials.gov/show/NCT00506415

Palabras clave

  1. 17/4/16 17/4/16 -
  2. 20/9/21 20/9/21 -
Subido en

20 de septiembre de 2021

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Alzheimer Disease NCT00506415

Eligibility Alzheimer Disease NCT00506415

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients between 50 and 85 years of age with a diagnosis of probable alzheimers disease,
Descripción

female; age; alzheimers disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0086287
UMLS CUI [1,2]
C0001779
UMLS CUI [2]
C0002395
baseline mini-mental state examination (mmse) score 10-24 inclusive,
Descripción

mini-mental state examination score

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0451306
a primary caregiver willing to accept responsibility for supervising treatment, assessing the patient's condition throughout the study, and for providing input into efficacy assessments.
Descripción

primary caregiver Compliance behavior

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1319883
UMLS CUI [1,2]
C1321605
for double blind only: meet the decline criteria of functional (as assessed by the investigator) and cognitive (assessed by a 1 point reduction in mini-mental state examination) score between visits or a 3 point reduction from baseline) decline at weeks 23, 36 or 48.
Descripción

mini-mental state examination score

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0451306
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of an advanced, severe, progressive, or unstable disease of any type that could interfere with efficacy and safety assessments or put the patient at particular risk,
Descripción

Compliance behavior Limited Comorbidity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
any medical or neurological condition other than alzheimers disease that could explain the patient's dementia,
Descripción

neurological condition; dementia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0497327
a diagnosis of probable or possible vascular dementia,
Descripción

vascular dementia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011269
a current diagnosis of unsuccessfully-treated depression, or any other mental disorder that may interfere with the evaluation of the patient's response to study medication,
Descripción

Compliance behavior Limited Comorbidity depression

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
UMLS CUI [1,4]
C0011570
a history or current diagnosis of cerebrovascular disease (e.g. stroke),
Descripción

cerebrovascular disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007820
a current diagnosis of severe or unstable cardiovascular disease (e.g. unstable coronary artery disease).
Descripción

cardiovascular disease; coronary artery disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C1956346
other protocol-defined inclusion/exclusion criteria may apply.
Descripción

inclusion; exclusion criteria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1512693
UMLS CUI [2]
C0680251

Similar models

Eligibility Alzheimer Disease NCT00506415

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
female; age; alzheimers disease
Item
male or female patients between 50 and 85 years of age with a diagnosis of probable alzheimers disease,
boolean
C0086287 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0002395 (UMLS CUI [2])
mini-mental state examination score
Item
baseline mini-mental state examination (mmse) score 10-24 inclusive,
boolean
C0451306 (UMLS CUI [1])
primary caregiver Compliance behavior
Item
a primary caregiver willing to accept responsibility for supervising treatment, assessing the patient's condition throughout the study, and for providing input into efficacy assessments.
boolean
C1319883 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
mini-mental state examination score
Item
for double blind only: meet the decline criteria of functional (as assessed by the investigator) and cognitive (assessed by a 1 point reduction in mini-mental state examination) score between visits or a 3 point reduction from baseline) decline at weeks 23, 36 or 48.
boolean
C0451306 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Compliance behavior Limited Comorbidity
Item
presence of an advanced, severe, progressive, or unstable disease of any type that could interfere with efficacy and safety assessments or put the patient at particular risk,
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
neurological condition; dementia
Item
any medical or neurological condition other than alzheimers disease that could explain the patient's dementia,
boolean
C0027765 (UMLS CUI [1])
C0497327 (UMLS CUI [2])
vascular dementia
Item
a diagnosis of probable or possible vascular dementia,
boolean
C0011269 (UMLS CUI [1])
Compliance behavior Limited Comorbidity depression
Item
a current diagnosis of unsuccessfully-treated depression, or any other mental disorder that may interfere with the evaluation of the patient's response to study medication,
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0011570 (UMLS CUI [1,4])
cerebrovascular disease
Item
a history or current diagnosis of cerebrovascular disease (e.g. stroke),
boolean
C0007820 (UMLS CUI [1])
cardiovascular disease; coronary artery disease
Item
a current diagnosis of severe or unstable cardiovascular disease (e.g. unstable coronary artery disease).
boolean
C0007222 (UMLS CUI [1])
C1956346 (UMLS CUI [2])
inclusion; exclusion criteria
Item
other protocol-defined inclusion/exclusion criteria may apply.
boolean
C1512693 (UMLS CUI [1])
C0680251 (UMLS CUI [2])

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