ID

12047

Descrição

Evaluation of the Efficacy and Safety of Azeliragon (TTP488) in Patients With Mild Alzheimer's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02080364

Link

https://clinicaltrials.gov/show/NCT02080364

Palavras-chave

  1. 04/09/2015 04/09/2015 - Julian Varghese
Transferido a

4 de setembro de 2015

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Alzheimer's Disease NCT02080364

Eligibility Alzheimer's Disease NCT02080364

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of probable alzheimer disease (ad) with documented evidence of progression of disease
Descrição

evidence of progression; progression of disease; diagnosis; probable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1301725
UMLS CUI [1,3]
C0332307
UMLS CUI [2]
C0242656
UMLS CUI [3]
C0011900
UMLS CUI [4]
C1709683
mini mental state examination (mmse) score of 21-26, inclusive
Descrição

examination; score; mental; state

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0260877
UMLS CUI [2]
C0449820
UMLS CUI [3]
C0004936
UMLS CUI [4,1]
C1442065
UMLS CUI [4,2]
C0805701
UMLS CUI [4,3]
C0027361
clinical dementia rating global score of 0.5 or 1
Descrição

clinical; dementia; score

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0205210
UMLS CUI [2]
C0497327
UMLS CUI [3]
C0449820
rosen-modified hachinski ischemia score less than or equal to 4
Descrição

ischemia; score

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0340561
UMLS CUI [2]
C0449820
brain magnetic resonance imaging (mri) consistent with the diagnosis of probable ad
Descrição

magnetic resonance imaging; diagnosis; probable; brain; mri

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0024485
UMLS CUI [2]
C0011900
UMLS CUI [3]
C1709683
UMLS CUI [4]
C0006104
UMLS CUI [5]
C0024485
concurrent use of cholinesterase inhibitor or memantine with stable dose for at least 3 months prior to randomization
Descrição

cholinesterase; randomization; memantine; stable; dose

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0202207
UMLS CUI [2,1]
C1522541
UMLS CUI [2,2]
C1515944
UMLS CUI [2,3]
C0332307
UMLS CUI [2,4]
C0034656
UMLS CUI [3]
C0025242
UMLS CUI [4]
C0205360
UMLS CUI [5]
C3174092
caregiver willing to participate and be able to attend clinic visits with patient
Descrição

no code found

Tipo de dados

boolean

ability to ingest oral medications
Descrição

medications; oral

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0488501
UMLS CUI [2]
C0442027
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
significant neurological or psychiatric disease other than alzheimer's disease
Descrição

alzheimer's disease; neurological; other

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0002395
UMLS CUI [2,1]
C0449438
UMLS CUI [2,2]
C0205494
UMLS CUI [2,3]
C0031809
UMLS CUI [2,4]
C0030705
UMLS CUI [3,1]
C1533734
UMLS CUI [3,2]
C1512699
UMLS CUI [3,3]
C0205394
UMLS CUI [3,4]
C0013227
participants with evidence or history of severe drug allergies (resulting in dyspnea or severe rash).
Descrição

participants; allergies; dyspnea; severe; drug; rash

Tipo de dados

boolean

Alias
UMLS CUI [1]
CL106596
UMLS CUI [2]
C0020517
UMLS CUI [3]
C0013404
UMLS CUI [4]
C0205082
UMLS CUI [5]
C0013227
UMLS CUI [6]
C0015230
any contraindications to mri (e.g., clinically significant claustrophobia, non-removable ferromagnetic implants). patients with contraindications to mri may undergo computed tomography (ct) on approval by sponsor.
Descrição

clinically significant; computed tomography; contraindications; mri; non

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2826633
UMLS CUI [2]
C0040405
UMLS CUI [3,1]
C0522473
UMLS CUI [3,2]
C0003015
UMLS CUI [4]
C0024485
UMLS CUI [5]
C3530214
any contraindications to the fdg-pet study (e.g. allergy to any component of the fdg dose) in the cohort undergoing a pet scan.
Descrição

contraindications; component; pet scan; allergy; cohort; study; dose

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0522473
UMLS CUI [1,2]
C0003015
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0027365
UMLS CUI [2,3]
C0008902
UMLS CUI [3]
C0032743
UMLS CUI [4]
C0020517
UMLS CUI [5,1]
C1881010
UMLS CUI [5,2]
C0332307
UMLS CUI [5,3]
C0205390
UMLS CUI [6]
C0008976
UMLS CUI [7]
C3174092
previous exposure to investigational or non-investigational therapies for alzheimer's disease within 6 months of screening
Descrição

alzheimer's disease; screening; therapies; exposure; non

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0002395
UMLS CUI [2]
C1409616
UMLS CUI [3]
C0087111
UMLS CUI [4]
C0332157
UMLS CUI [5]
C3530214
history of cancer within the last 5 years except adequately treated cervical carcinoma in-situ, cutaneous basal cell or squamous cell cancer, or non-progressive prostate cancer not requiring treatment
Descrição

prostate; treatment; cutaneous; cervical; squamous; cancer; last; non

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0033572
UMLS CUI [2]
C0087111
UMLS CUI [3]
C0221912
UMLS CUI [4]
C0205064
UMLS CUI [5]
C1182670
UMLS CUI [6]
C0006826
UMLS CUI [7,1]
C2986440
UMLS CUI [7,2]
C1517741
UMLS CUI [8]
C3530214
women of childbearing potential
Descrição

childbearing potential

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1960468
uncontrolled blood pressure and/or blood pressure above 160/100
Descrição

blood pressure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005823
prescription medical food intended for dietary management of the metabolic processes associated with alzheimer's disease.
Descrição

alzheimer's disease; prescription; food

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0002395
UMLS CUI [2]
C1521941
UMLS CUI [3]
C0016452

Similar models

Eligibility Alzheimer's Disease NCT02080364

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
evidence of progression; progression of disease; diagnosis; probable
Item
diagnosis of probable alzheimer disease (ad) with documented evidence of progression of disease
boolean
C1457887 (UMLS CUI [1,1])
C1301725 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0242656 (UMLS CUI [2])
C0011900 (UMLS CUI [3])
C1709683 (UMLS CUI [4])
examination; score; mental; state
Item
mini mental state examination (mmse) score of 21-26, inclusive
boolean
C0260877 (UMLS CUI [1])
C0449820 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
C1442065 (UMLS CUI [4,1])
C0805701 (UMLS CUI [4,2])
C0027361 (UMLS CUI [4,3])
clinical; dementia; score
Item
clinical dementia rating global score of 0.5 or 1
boolean
C0205210 (UMLS CUI [1])
C0497327 (UMLS CUI [2])
C0449820 (UMLS CUI [3])
ischemia; score
Item
rosen-modified hachinski ischemia score less than or equal to 4
boolean
C0340561 (UMLS CUI [1])
C0449820 (UMLS CUI [2])
magnetic resonance imaging; diagnosis; probable; brain; mri
Item
brain magnetic resonance imaging (mri) consistent with the diagnosis of probable ad
boolean
C0024485 (UMLS CUI [1])
C0011900 (UMLS CUI [2])
C1709683 (UMLS CUI [3])
C0006104 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
cholinesterase; randomization; memantine; stable; dose
Item
concurrent use of cholinesterase inhibitor or memantine with stable dose for at least 3 months prior to randomization
boolean
C0202207 (UMLS CUI [1])
C1522541 (UMLS CUI [2,1])
C1515944 (UMLS CUI [2,2])
C0332307 (UMLS CUI [2,3])
C0034656 (UMLS CUI [2,4])
C0025242 (UMLS CUI [3])
C0205360 (UMLS CUI [4])
C3174092 (UMLS CUI [5])
no code found
Item
caregiver willing to participate and be able to attend clinic visits with patient
boolean
medications; oral
Item
ability to ingest oral medications
boolean
C0488501 (UMLS CUI [1])
C0442027 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
alzheimer's disease; neurological; other
Item
significant neurological or psychiatric disease other than alzheimer's disease
boolean
C0002395 (UMLS CUI [1])
C0449438 (UMLS CUI [2,1])
C0205494 (UMLS CUI [2,2])
C0031809 (UMLS CUI [2,3])
C0030705 (UMLS CUI [2,4])
C1533734 (UMLS CUI [3,1])
C1512699 (UMLS CUI [3,2])
C0205394 (UMLS CUI [3,3])
C0013227 (UMLS CUI [3,4])
participants; allergies; dyspnea; severe; drug; rash
Item
participants with evidence or history of severe drug allergies (resulting in dyspnea or severe rash).
boolean
CL106596 (UMLS CUI [1])
C0020517 (UMLS CUI [2])
C0013404 (UMLS CUI [3])
C0205082 (UMLS CUI [4])
C0013227 (UMLS CUI [5])
C0015230 (UMLS CUI [6])
clinically significant; computed tomography; contraindications; mri; non
Item
any contraindications to mri (e.g., clinically significant claustrophobia, non-removable ferromagnetic implants). patients with contraindications to mri may undergo computed tomography (ct) on approval by sponsor.
boolean
C2826633 (UMLS CUI [1])
C0040405 (UMLS CUI [2])
C0522473 (UMLS CUI [3,1])
C0003015 (UMLS CUI [3,2])
C0024485 (UMLS CUI [4])
C3530214 (UMLS CUI [5])
contraindications; component; pet scan; allergy; cohort; study; dose
Item
any contraindications to the fdg-pet study (e.g. allergy to any component of the fdg dose) in the cohort undergoing a pet scan.
boolean
C0522473 (UMLS CUI [1,1])
C0003015 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2,1])
C0027365 (UMLS CUI [2,2])
C0008902 (UMLS CUI [2,3])
C0032743 (UMLS CUI [3])
C0020517 (UMLS CUI [4])
C1881010 (UMLS CUI [5,1])
C0332307 (UMLS CUI [5,2])
C0205390 (UMLS CUI [5,3])
C0008976 (UMLS CUI [6])
C3174092 (UMLS CUI [7])
alzheimer's disease; screening; therapies; exposure; non
Item
previous exposure to investigational or non-investigational therapies for alzheimer's disease within 6 months of screening
boolean
C0002395 (UMLS CUI [1])
C1409616 (UMLS CUI [2])
C0087111 (UMLS CUI [3])
C0332157 (UMLS CUI [4])
C3530214 (UMLS CUI [5])
prostate; treatment; cutaneous; cervical; squamous; cancer; last; non
Item
history of cancer within the last 5 years except adequately treated cervical carcinoma in-situ, cutaneous basal cell or squamous cell cancer, or non-progressive prostate cancer not requiring treatment
boolean
C0033572 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
C0221912 (UMLS CUI [3])
C0205064 (UMLS CUI [4])
C1182670 (UMLS CUI [5])
C0006826 (UMLS CUI [6])
C2986440 (UMLS CUI [7,1])
C1517741 (UMLS CUI [7,2])
C3530214 (UMLS CUI [8])
childbearing potential
Item
women of childbearing potential
boolean
C1960468 (UMLS CUI [1])
blood pressure
Item
uncontrolled blood pressure and/or blood pressure above 160/100
boolean
C0005823 (UMLS CUI [1])
alzheimer's disease; prescription; food
Item
prescription medical food intended for dietary management of the metabolic processes associated with alzheimer's disease.
boolean
C0002395 (UMLS CUI [1])
C1521941 (UMLS CUI [2])
C0016452 (UMLS CUI [3])

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