ID

14195

Beschrijving

Efficacy Study of MPC-7869 to Treat Patients With Alzheimer's; ODM derived from: https://clinicaltrials.gov/show/NCT00105547

Link

https://clinicaltrials.gov/show/NCT00105547

Trefwoorden

  1. 04-04-16 04-04-16 -
Geüploaded op

4 april 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Alzheimer Disease NCT00105547

Eligibility Alzheimer Disease NCT00105547

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
have had a diagnosis of probable alzheimer's disease.
Beschrijving

alzheimers disease

Datatype

boolean

Alias
UMLS CUI [1]
C0002395
men or women ages 55 years or greater and living in the community at the time of enrollment (i.e., not living in a rest home or nursing care facility).
Beschrijving

gender; age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
signed the subject informed consent form and is willing and able to participate for the duration of the study.
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
ability to read and understand english or spanish to ensure compliance with cognitive testing and study visit procedures.
Beschrijving

english speaking

Datatype

boolean

Alias
UMLS CUI [1]
C0376245
female subjects must be surgically sterile or postmenopausal for > 1 year.
Beschrijving

Contraception status; postmenopausal

Datatype

boolean

Alias
UMLS CUI [1]
C0420837
UMLS CUI [2]
C0232970
subjects currently taking approved medication for alzheimer's disease for at least six months prior to day 1 may be enrolled.
Beschrijving

medication alzheimers disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0002395
subjects must have a reliable caregiver who can read, understand and speak english or spanish.
Beschrijving

caregiver; english speaking

Datatype

boolean

Alias
UMLS CUI [1]
C0085537
UMLS CUI [2]
C0376245
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
current evidence of other causes of dementia.
Beschrijving

dementia

Datatype

boolean

Alias
UMLS CUI [1]
C0497327
history or evidence of, active malignancy, except for basal cell carcinoma or squamous cell carcinoma of the skin, within the 24 months prior to entry. men with prostate cancer may be enrolled at the discretion of the sponsor.
Beschrijving

malignancy; basal cell carcinoma; Squamous cell carcinoma of skin; prostate cancer

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0553723
UMLS CUI [4]
C0600139
chronic or acute renal, hepatic or metabolic disorder.
Beschrijving

renal disorder; hepatic disease; metabolic disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0025517
use of any investigational therapy within 30 days, or 5 half-lives, whichever is longer, and/or use of ad immunotherapy prior to screening.
Beschrijving

immunotherapy; investigational therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0021083
UMLS CUI [2]
C0949266
major surgery and related complications not resolved within 12 weeks prior to day 1.
Beschrijving

major surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0679637

Similar models

Eligibility Alzheimer Disease NCT00105547

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
alzheimers disease
Item
have had a diagnosis of probable alzheimer's disease.
boolean
C0002395 (UMLS CUI [1])
gender; age
Item
men or women ages 55 years or greater and living in the community at the time of enrollment (i.e., not living in a rest home or nursing care facility).
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
informed consent
Item
signed the subject informed consent form and is willing and able to participate for the duration of the study.
boolean
C0021430 (UMLS CUI [1])
english speaking
Item
ability to read and understand english or spanish to ensure compliance with cognitive testing and study visit procedures.
boolean
C0376245 (UMLS CUI [1])
Contraception status; postmenopausal
Item
female subjects must be surgically sterile or postmenopausal for > 1 year.
boolean
C0420837 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
medication alzheimers disease
Item
subjects currently taking approved medication for alzheimer's disease for at least six months prior to day 1 may be enrolled.
boolean
C0013227 (UMLS CUI [1,1])
C0002395 (UMLS CUI [1,2])
caregiver; english speaking
Item
subjects must have a reliable caregiver who can read, understand and speak english or spanish.
boolean
C0085537 (UMLS CUI [1])
C0376245 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
dementia
Item
current evidence of other causes of dementia.
boolean
C0497327 (UMLS CUI [1])
malignancy; basal cell carcinoma; Squamous cell carcinoma of skin; prostate cancer
Item
history or evidence of, active malignancy, except for basal cell carcinoma or squamous cell carcinoma of the skin, within the 24 months prior to entry. men with prostate cancer may be enrolled at the discretion of the sponsor.
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0553723 (UMLS CUI [3])
C0600139 (UMLS CUI [4])
renal disorder; hepatic disease; metabolic disorder
Item
chronic or acute renal, hepatic or metabolic disorder.
boolean
C0022658 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0025517 (UMLS CUI [3])
immunotherapy; investigational therapy
Item
use of any investigational therapy within 30 days, or 5 half-lives, whichever is longer, and/or use of ad immunotherapy prior to screening.
boolean
C0021083 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
major surgery
Item
major surgery and related complications not resolved within 12 weeks prior to day 1.
boolean
C0679637 (UMLS CUI [1])

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