Information:
Fel:
ID
14799
Beskrivning
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
Länk
https://clinicaltrials.gov/show/NCT01584440
Nyckelord
Versioner (1)
- 2016-04-28 2016-04-28 -
Uppladdad den
28 april 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Agitation NCT01584440
Eligibility Agitation NCT01584440
- StudyEvent: Eligibility
Similar models
Eligibility Agitation NCT01584440
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
C0009488 (UMLS CUI [2])
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])
C0009488 (UMLS CUI [2])
myasthenia gravis
Item
patients with myasthenia gravis.
boolean
C0026896 (UMLS CUI [1])