ID

44002

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00322036

Nyckelord

  1. 2016-04-05 2016-04-05 -
  2. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Alzheimer Disease NCT00322036

Eligibility Alzheimer Disease NCT00322036

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693 (Inclusion)
1. have had a diagnosis of probable alzheimer's disease
Beskrivning

alzheimers disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0002395 (Alzheimer's Disease)
SNOMED
26929004
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).
Beskrivning

gender; age

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399 (Gender)
SNOMED
263495000
LOINC
LP61312-2
UMLS CUI [2]
C0001779 (Age)
SNOMED
424144002
LOINC
LP28815-6
3. signed the subject informed consent form (icf) and is willing and able to participate for the duration of the study.
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430 (Informed Consent)
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.
Beskrivning

language comprehension

Datatyp

boolean

Alias
UMLS CUI [1]
C0233733 (Language comprehension)
SNOMED
46977006
5. at least 6 years of education, or sufficient work history to exclude mental retardation.
Beskrivning

mental retardation; education

Datatyp

boolean

Alias
UMLS CUI [1]
C0025362 (Mental Retardation)
UMLS CUI [2]
C0013658 (Educational Status)
SNOMED
266981003
6. female subjects must be surgically sterile or postmenopausal for > 1 year.
Beskrivning

contraception status female; postmenopausal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0420837 (Contraception status)
SNOMED
243816001
UMLS CUI [1,2]
C0086287 (Females)
SNOMED
1086007
UMLS CUI [2]
C0232970 (Postmenopausal state)
SNOMED
76498008
7. adequate vision and hearing to participate in study assessments.
Beskrivning

vision; hearing

Datatyp

boolean

Alias
UMLS CUI [1]
C0042789 (Vision)
SNOMED
281004000
LOINC
LP30560-4
UMLS CUI [2]
C0018767 (Hearing)
SNOMED
47078008
LOINC
LP30518-2
8. subjects must have a reliable caregiver who can read, understand and speak same language.
Beskrivning

caregiver

Datatyp

boolean

Alias
UMLS CUI [1]
C0085537 (Caregiver)
SNOMED
133932002
LOINC
LP76010-5
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251 (Exclusion Criteria)
1. current evidence of other causes of dementia.. .
Beskrivning

dementia

Datatyp

boolean

Alias
UMLS CUI [1]
C0497327 (Dementia)
SNOMED
52448006
LOINC
LA20372-1
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.
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826 (Malignant Neoplasms)
SNOMED
363346000
LOINC
LP100805-3
UMLS CUI [2]
C0007117 (Basal cell carcinoma)
SNOMED
1338007
UMLS CUI [3]
C0007137 (Squamous cell carcinoma)
SNOMED
28899001
LOINC
LP17968-6
UMLS CUI [4]
C0600139 (Prostate carcinoma)
SNOMED
254900004
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.
Beskrivning

investigational therapy; immunotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0949266 (Therapies, Investigational)
UMLS CUI [1,2]
C0205420 (Concurrent)
SNOMED
68405009
UMLS CUI [2]
C0021083 (Immunotherapy)
SNOMED
76334006
4. major surgery and related complications not resolved within 12 weeks prior to day 1.
Beskrivning

major surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637 (major surgery)
5. previous participation in an mpc-7869 clinical study.
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568 (Study Subject Participation Status)

Similar models

Eligibility Alzheimer Disease NCT00322036

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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