ID

14799

Description

Efficacy, Safety and Tolerability Study of AVP-923 (Dextromethorphan/Quinidine) for Treatment of Symptoms of Agitation in Alzheimer's Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01584440

Link

https://clinicaltrials.gov/show/NCT01584440

Keywords

Versions (1)
  1. 4/28/16 4/28/16 -
Uploaded on

April 28, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Agitation NCT01584440

English

Eligibility Agitation NCT01584440

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Agitation NCT01584440
Inclusion Criteria
Description

Inclusion Criteria

diagnosis of probable alzheimer's disease (ad).
Description

Alzheimer's Disease

Data type

boolean

Alias
UMLS CUI [1]
C0002395
the patient has clinically significant symptoms of agitation secondary to ad, that interfere with daily routine and for which a prescription medication is deemed indicated, in the opinion of the investigator.
Description

Agitation

Data type

boolean

Alias
UMLS CUI [1]
C0085631
either out-patients or residents of an assisted-living facility or a skilled nursing home.
Description

living in assisted living facility

Data type

boolean

Alias
UMLS CUI [1]
C2136015
cgi-s score is ≥ 4 (moderately ill) at screening and baseline.
Description

cgi-s score

Data type

boolean

Alias
UMLS CUI [1]
C3639708
mini mental state examination (mmse) score at screening between 8 and 28 (inclusive).
Description

mini mental state examination

Data type

boolean

Alias
UMLS CUI [1]
C0451306
caregiver who is able and willing to comply with all required study procedures, ensuring that the patient attends all study visits and takes the study medication as instructed. in order to qualify as a caregiver for this study, the individual should spend time with the patient for a minimum of 4 hours on 4 separate days per week.
Description

Protocol Compliance Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0009488
Exclusion criteria
Description

Exclusion criteria

patient has other type of dementia (e.g., vascular dementia, frontotemporal dementia, parkinson's disease, substance-induced dementia).
Description

dementia

Data type

boolean

Alias
UMLS CUI [1]
C0497327
patients with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g. malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, certain cardiac conduction abnormalities including qtc prolongation, or unstable valvular heart disease).
Description

confound the interpretation of the safety results of the study

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0009488
patients with myasthenia gravis.
Description

myasthenia gravis

Data type

boolean

Alias
UMLS CUI [1]
C0026896
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Similar models

Eligibility Agitation NCT01584440

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Agitation NCT01584440
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Alzheimer's Disease
Item
diagnosis of probable alzheimer's disease (ad).
boolean
C0002395 (UMLS CUI [1])
Agitation
Item
the patient has clinically significant symptoms of agitation secondary to ad, that interfere with daily routine and for which a prescription medication is deemed indicated, in the opinion of the investigator.
boolean
C0085631 (UMLS CUI [1])
living in assisted living facility
Item
either out-patients or residents of an assisted-living facility or a skilled nursing home.
boolean
C2136015 (UMLS CUI [1])
cgi-s score
Item
cgi-s score is ≥ 4 (moderately ill) at screening and baseline.
boolean
C3639708 (UMLS CUI [1])
mini mental state examination
Item
mini mental state examination (mmse) score at screening between 8 and 28 (inclusive).
boolean
C0451306 (UMLS CUI [1])
Protocol Compliance Comorbidity
Item
caregiver who is able and willing to comply with all required study procedures, ensuring that the patient attends all study visits and takes the study medication as instructed. in order to qualify as a caregiver for this study, the individual should spend time with the patient for a minimum of 4 hours on 4 separate days per week.
boolean
C0525058 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
Item Group
Exclusion criteria
dementia
Item
patient has other type of dementia (e.g., vascular dementia, frontotemporal dementia, parkinson's disease, substance-induced dementia).
boolean
C0497327 (UMLS CUI [1])
confound the interpretation of the safety results of the study
Item
patients with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g. malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, certain cardiac conduction abnormalities including qtc prolongation, or unstable valvular heart disease).
boolean
C0525058 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
myasthenia gravis
Item
patients with myasthenia gravis.
boolean
C0026896 (UMLS CUI [1])
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