ID

14846

Description

Efficacy, Safety and Tolerability of AVP-786 (Deuterated [d6]-Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type; ODM derived from: https://clinicaltrials.gov/show/NCT02442765

Link

https://clinicaltrials.gov/show/NCT02442765

Keywords

Versions (1)
  1. 5/1/16 5/1/16 -
Uploaded on

May 1, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Agitation in Patients With Dementia of the Alzheimer's Type NCT02442765

English

Eligibility Agitation in Patients With Dementia of the Alzheimer's Type NCT02442765

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of probable alzheimer's disease (ad)
Description

alzheimer's disease

Data type

boolean

Alias
UMLS CUI [1]
C0002395
the patient has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization
Description

ID.2

Data type

boolean

the diagnosis of agitation must meet the ipa provisional definition of agitation
Description

diagnosis of 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

Outpatients

Data type

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C2136015
cgis score assessing agitation is >= 4 (moderately ill) at screening and baseline
Description

Clinical Global Impressions Scale

Data type

boolean

Alias
UMLS CUI [1]
C3639708
mmse score is between 6 and 26 (inclusive) at screening and baseline
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. in order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in patient's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the patient
Description

Caregiver

Data type

boolean

Alias
UMLS CUI [1]
C0085537
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has dementia predominantly of non-alzheimer's type (e.g., vascular dementia, frontotemporal dementia, parkinson's disease, substance-induced dementia)
Description

Dementia (excl Alzheimer's type)

Data type

boolean

Alias
UMLS CUI [1]
C0852408
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, or unstable valvular heart disease)
Description

Protocol Compliance Comorbidity

Data type

boolean

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

myasthenia gravis

Data type

boolean

Alias
UMLS CUI [1]
C0026896
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Similar models

Eligibility Agitation in Patients With Dementia of the Alzheimer's Type NCT02442765

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
alzheimer's disease
Item
diagnosis of probable alzheimer's disease (ad)
boolean
C0002395 (UMLS CUI [1])
ID.2
Item
the patient has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization
boolean
diagnosis of agitation
Item
the diagnosis of agitation must meet the ipa provisional definition of agitation
boolean
C0085631 (UMLS CUI [1])
Outpatients
Item
either out patients or residents of an assisted-living facility or a skilled nursing home
boolean
C0029921 (UMLS CUI [1])
C2136015 (UMLS CUI [2])
Clinical Global Impressions Scale
Item
cgis score assessing agitation is >= 4 (moderately ill) at screening and baseline
boolean
C3639708 (UMLS CUI [1])
Mini-mental state examination
Item
mmse score is between 6 and 26 (inclusive) at screening and baseline
boolean
C0451306 (UMLS CUI [1])
Caregiver
Item
caregiver who is able and willing to comply with all required study procedures. in order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in patient's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the patient
boolean
C0085537 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Dementia (excl Alzheimer's type)
Item
patient has dementia predominantly of non-alzheimer's type (e.g., vascular dementia, frontotemporal dementia, parkinson's disease, substance-induced dementia)
boolean
C0852408 (UMLS CUI [1])
Protocol Compliance Comorbidity
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, or unstable valvular heart disease)
boolean
C0525058 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
myasthenia gravis
Item
patient with myasthenia gravis
boolean
C0026896 (UMLS CUI [1])
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