ID

44002

Description

Global Efficacy Study of MPC-7869 to Treat Patients With Alzheimer's; ODM derived from: https://clinicaltrials.gov/show/NCT00322036

Link

https://clinicaltrials.gov/show/NCT00322036

Keywords

  1. 4/5/16 4/5/16 -
  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 NCT00322036

Eligibility Alzheimer Disease NCT00322036

Inclusion Criteria
Description

Inclusion Criteria

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

alzheimers disease

Data type

boolean

Alias
UMLS CUI [1]
C0002395
2. men or women ages greater than or equal to 55 years and living in the community at the time of enrollment (ie, not living in a rest home or nursing care facility).
Description

gender; age

Data type

boolean

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

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
4. ability to read and understand english, dutch, danish, flemish, french, german, italian, spanish or swedish to ensure compliance with cognitive testing and study visit procedures.
Description

language comprehension

Data type

boolean

Alias
UMLS CUI [1]
C0233733
5. at least 6 years of education, or sufficient work history to exclude mental retardation.
Description

mental retardation; education

Data type

boolean

Alias
UMLS CUI [1]
C0025362
UMLS CUI [2]
C0013658
6. female subjects must be surgically sterile or postmenopausal for > 1 year.
Description

contraception status female; postmenopausal

Data type

boolean

Alias
UMLS CUI [1,1]
C0420837
UMLS CUI [1,2]
C0086287
UMLS CUI [2]
C0232970
7. adequate vision and hearing to participate in study assessments.
Description

vision; hearing

Data type

boolean

Alias
UMLS CUI [1]
C0042789
UMLS CUI [2]
C0018767
8. subjects must have a reliable caregiver who can read, understand and speak same language.
Description

caregiver

Data type

boolean

Alias
UMLS CUI [1]
C0085537
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. current evidence of other causes of dementia.. .
Description

dementia

Data type

boolean

Alias
UMLS CUI [1]
C0497327
2. history of, 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.
Description

malignancy; basal cell carcinoma; squamous cell carcinoma ; prostate cancer

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0007137
UMLS CUI [4]
C0600139
3. use of any investigational therapy within 30 days, or 5 half-lives, whichever is longer, and/or use of ad immunotherapy prior to screening.
Description

investigational therapy; immunotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0949266
UMLS CUI [1,2]
C0205420
UMLS CUI [2]
C0021083
4. major surgery and related complications not resolved within 12 weeks prior to day 1.
Description

major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
5. previous participation in an mpc-7869 clinical study.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Alzheimer Disease NCT00322036

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
alzheimers disease
Item
1. have had a diagnosis of probable alzheimer's disease
boolean
C0002395 (UMLS CUI [1])
gender; age
Item
2. men or women ages greater than or equal to 55 years and living in the community at the time of enrollment (ie, not living in a rest home or nursing care facility).
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
informed consent
Item
3. signed the subject informed consent form (icf) and is willing and able to participate for the duration of the study.
boolean
C0021430 (UMLS CUI [1])
language comprehension
Item
4. ability to read and understand english, dutch, danish, flemish, french, german, italian, spanish or swedish to ensure compliance with cognitive testing and study visit procedures.
boolean
C0233733 (UMLS CUI [1])
mental retardation; education
Item
5. at least 6 years of education, or sufficient work history to exclude mental retardation.
boolean
C0025362 (UMLS CUI [1])
C0013658 (UMLS CUI [2])
contraception status female; postmenopausal
Item
6. female subjects must be surgically sterile or postmenopausal for > 1 year.
boolean
C0420837 (UMLS CUI [1,1])
C0086287 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2])
vision; hearing
Item
7. adequate vision and hearing to participate in study assessments.
boolean
C0042789 (UMLS CUI [1])
C0018767 (UMLS CUI [2])
caregiver
Item
8. subjects must have a reliable caregiver who can read, understand and speak same language.
boolean
C0085537 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
dementia
Item
1. current evidence of other causes of dementia.. .
boolean
C0497327 (UMLS CUI [1])
malignancy; basal cell carcinoma; squamous cell carcinoma ; prostate cancer
Item
2. history of, 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])
C0007137 (UMLS CUI [3])
C0600139 (UMLS CUI [4])
investigational therapy; immunotherapy
Item
3. 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
C0949266 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
C0021083 (UMLS CUI [2])
major surgery
Item
4. major surgery and related complications not resolved within 12 weeks prior to day 1.
boolean
C0679637 (UMLS CUI [1])
Study Subject Participation Status
Item
5. previous participation in an mpc-7869 clinical study.
boolean
C2348568 (UMLS CUI [1])

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