Information:
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ID
14842
Description
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
Keywords
Versions (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 Alzheimer's Disease NCT02446132
Eligibility Agitation in Alzheimer's Disease NCT02446132
- StudyEvent: Eligibility
Similar models
Eligibility Agitation in Alzheimer's Disease NCT02446132
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
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])
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])
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])