Informações:
Falhas:
ID
14846
Descrição
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
Palavras-chave
Versões (1)
- 01/05/2016 01/05/2016 -
Transferido a
1 de maio de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Agitation in Patients With Dementia of the Alzheimer's Type NCT02442765
Eligibility Agitation in Patients With Dementia of the Alzheimer's Type NCT02442765
- StudyEvent: Eligibility
Similar models
Eligibility Agitation in Patients With Dementia of the Alzheimer's Type NCT02442765
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
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])
C0009488 (UMLS CUI [2])
myasthenia gravis
Item
patient with myasthenia gravis
boolean
C0026896 (UMLS CUI [1])