ID

12047

Beschreibung

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

Stichworte

Versionen (1)
  1. 04.09.15 04.09.15 - Julian Varghese
Hochgeladen am

4. September 2015

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Alzheimer's Disease NCT02080364

Englisch

Eligibility Alzheimer's Disease NCT02080364

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

evidence of progression; progression of disease; diagnosis; probable

Datentyp

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
Beschreibung

examination; score; mental; state

Datentyp

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
Beschreibung

clinical; dementia; score

Datentyp

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
Beschreibung

ischemia; score

Datentyp

boolean

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

magnetic resonance imaging; diagnosis; probable; brain; mri

Datentyp

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
Beschreibung

cholinesterase; randomization; memantine; stable; dose

Datentyp

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
Beschreibung

no code found

Datentyp

boolean

ability to ingest oral medications
Beschreibung

medications; oral

Datentyp

boolean

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

Exclusion Criteria

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

alzheimer's disease; neurological; other

Datentyp

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).
Beschreibung

participants; allergies; dyspnea; severe; drug; rash

Datentyp

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.
Beschreibung

clinically significant; computed tomography; contraindications; mri; non

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

childbearing potential

Datentyp

boolean

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

blood pressure

Datentyp

boolean

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

alzheimer's disease; prescription; food

Datentyp

boolean

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

Eligibility Alzheimer's Disease NCT02080364

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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