ID

14842

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02446132

Nyckelord

  1. 2016-05-01 2016-05-01 -
Uppladdad den

1 maj 2016

DOI

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Licens

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
Beskrivning

Inclusion Criteria

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

Study status

Datatyp

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.
Beskrivning

Alzheimers Disease

Datatyp

boolean

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

out-patients, assisted-living facility

Datatyp

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.
Beskrivning

agitation

Datatyp

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.
Beskrivning

IPA agiation

Datatyp

boolean

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

cgis score

Datatyp

boolean

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

Mini–mental state examination

Datatyp

boolean

Alias
UMLS CUI [1]
C0451306
Exclusion Criteria
Beskrivning

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).
Beskrivning

Protocol Compliance Comorbidity

Datatyp

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.
Beskrivning

At risk for falls

Datatyp

boolean

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

Nuedexta

Datatyp

boolean

Alias
UMLS CUI [1]
C2954623

Similar models

Eligibility Agitation in Alzheimer's Disease NCT02446132

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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