ID

12756

Descripción

A Study of Single and Multiple Doses of KHK6640 in Subjects With Prodromal or Mild to Moderate Alzheimer's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02127476

Link

https://clinicaltrials.gov/show/NCT02127476

Palabras clave

  1. 21/12/15 21/12/15 -
Subido en

21 de diciembre de 2015

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Alzheimer's Disease DRKS00007287 NCT02127476

Eligibility Alzheimer's Disease NCT02127476

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with prodromal ad or mild to moderate ad
Descripción

Prodromal Alzheimer disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3805054
clinical dementia rating (cdr) score of 0.5, 1.0, or 2.0
Descripción

Clinical dementia rating scale

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0451074
have a cognitive impairment
Descripción

Impaired cognition

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0338656
low aβ and high tau in cerebrospinal fluid (csf)
Descripción

tau Proteins; cerebrospinal fluid

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0085401
UMLS CUI [2]
C0007806
mini mental state examination (mmse) score > 16 at screening
Descripción

Mini-mental state examination score

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2960235
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous active treatment with an ad immunotherapy in an investigational study
Descripción

Immunotherapy, Active; Alzheimers Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079612
UMLS CUI [2]
C0002395
use of another investigational drug within 30 days of screening
Descripción

Concomitant Agent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2347852
history or presence of clinically significant seizures, brain trauma, transient ischemic attack, and/or cerebrovascular disease
Descripción

Comorbidity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
presence of a neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's ad
Descripción

comorbidity neurological

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205494
evidence of infection, tumor, or other clinically significant lesions that could indicate a dementia diagnosis other than ad
Descripción

comorbidity; Dementia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0497327

Similar models

Eligibility Alzheimer's Disease NCT02127476

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Prodromal Alzheimer disease
Item
patients with prodromal ad or mild to moderate ad
boolean
C3805054 (UMLS CUI [1])
Clinical dementia rating scale
Item
clinical dementia rating (cdr) score of 0.5, 1.0, or 2.0
boolean
C0451074 (UMLS CUI [1])
Impaired cognition
Item
have a cognitive impairment
boolean
C0338656 (UMLS CUI [1])
tau Proteins; cerebrospinal fluid
Item
low aβ and high tau in cerebrospinal fluid (csf)
boolean
C0085401 (UMLS CUI [1])
C0007806 (UMLS CUI [2])
Mini-mental state examination score
Item
mini mental state examination (mmse) score > 16 at screening
boolean
C2960235 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Immunotherapy, Active; Alzheimers Disease
Item
previous active treatment with an ad immunotherapy in an investigational study
boolean
C0079612 (UMLS CUI [1])
C0002395 (UMLS CUI [2])
Concomitant Agent
Item
use of another investigational drug within 30 days of screening
boolean
C2347852 (UMLS CUI [1])
Comorbidity
Item
history or presence of clinically significant seizures, brain trauma, transient ischemic attack, and/or cerebrovascular disease
boolean
C0009488 (UMLS CUI [1])
comorbidity neurological
Item
presence of a neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's ad
boolean
C0009488 (UMLS CUI [1,1])
C0205494 (UMLS CUI [1,2])
comorbidity; Dementia
Item
evidence of infection, tumor, or other clinically significant lesions that could indicate a dementia diagnosis other than ad
boolean
C0009488 (UMLS CUI [1])
C0497327 (UMLS CUI [2])

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