ID

14842

Descripción

Long Term, Extension Study of the Safety and Efficacy 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/NCT02446132

Link

https://clinicaltrials.gov/show/NCT02446132

Palabras clave

  1. 1/5/16 1/5/16 -
Subido en

1 de mayo de 2016

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Agitation in Alzheimer's Disease NCT02446132

Eligibility Agitation in Alzheimer's Disease NCT02446132

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient has successfully completed studies 15-avp-786-301, 15-avp-786-302, or 12-avr-131
Descripción

Study status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
patients from study 12-avr-131 with a diagnosis of probable ad according to the 2011 nia-aa working group criteria.
Descripción

Alzheimers Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002395
either out-patients or residents of an assisted-living facility or a skilled nursing home.
Descripción

out-patients, assisted-living facility

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C2136015
patients from study 12-avr-131 who have clinically significant, moderate/severe agitation at least 2 weeks prior to baseline.
Descripción

agitation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1963060
patients from study 12-avr-131 with a diagnosis of agitation that must meet the ipa provisional definition of agitation.
Descripción

IPA agiation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0302807
patients from study 12-avr-131 with a cgis score assessing agitation of ≥ 4 (moderately ill) at baseline.
Descripción

cgis score

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3639708
patients from study 12-avr-131 with a mmse score between 6 and 26 (inclusive) at baseline.
Descripción

Mini–mental state examination

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0451306
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
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).
Descripción

Protocol Compliance Comorbidity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0009488
patients determined to have a high imminent risk of falls during the study based on a clinical evaluation by the investigator.
Descripción

At risk for falls

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1268740
patients who are currently using or were on nuedexta® in the 4 weeks preceding baseline.
Descripción

Nuedexta

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2954623

Similar models

Eligibility Agitation in Alzheimer's Disease NCT02446132

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Study status
Item
patient has successfully completed studies 15-avp-786-301, 15-avp-786-302, or 12-avr-131
boolean
C2348568 (UMLS CUI [1])
Alzheimers Disease
Item
patients from study 12-avr-131 with a diagnosis of probable ad according to the 2011 nia-aa working group criteria.
boolean
C0002395 (UMLS CUI [1])
out-patients, assisted-living facility
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])
agitation
Item
patients from study 12-avr-131 who have clinically significant, moderate/severe agitation at least 2 weeks prior to baseline.
boolean
C1963060 (UMLS CUI [1])
IPA agiation
Item
patients from study 12-avr-131 with a diagnosis of agitation that must meet the ipa provisional definition of agitation.
boolean
C0302807 (UMLS CUI [1])
cgis score
Item
patients from study 12-avr-131 with a cgis score assessing agitation of ≥ 4 (moderately ill) at baseline.
boolean
C3639708 (UMLS CUI [1])
Mini–mental state examination
Item
patients from study 12-avr-131 with a mmse score between 6 and 26 (inclusive) at baseline.
boolean
C0451306 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
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])
At risk for falls
Item
patients determined to have a high imminent risk of falls during the study based on a clinical evaluation by the investigator.
boolean
C1268740 (UMLS CUI [1])
Nuedexta
Item
patients who are currently using or were on nuedexta® in the 4 weeks preceding baseline.
boolean
C2954623 (UMLS CUI [1])

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