Efficacy, Safety and Tolerability Study of AVP-923 (Dextromethorphan/Quinidine) for Treatment of Symptoms of Agitation in Alzheimer's Patients
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|ClinicalTrials.gov Identifier: NCT01584440|
Recruitment Status : Completed
First Posted : April 25, 2012
Last Update Posted : January 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Agitation Alzheimer's Disease||Drug: AVP-923 (dextromethorphan/quinidine) Drug: Placebo||Phase 2|
Eligible patients for this study must have a diagnosis of probable AD and must have clinically meaningful agitation secondary to AD.
This is a multicenter, randomized, double-dummy, double-blind, placebo-controlled study, consisting of 10 weeks of treatment.
Up to 200 patients will be enrolled at approximately 30-40 centers in the US.
Study medication will be administered orally twice-daily from Day 1 through Day 70. Screening must occur within within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible patients will be randomized into the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2, Randomized, Double-dummy, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety and Tolerability of AVP-923 (Dextromethorphan/Quinidine) for the Treatment of Symptoms of Agitation in Patients With Alzheimer's Disease.|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||September 2014|
|Placebo Comparator: Placebo||
Placebo capsules administered twice a day over a 10-week period
Drug: AVP-923 (dextromethorphan/quinidine)
AVP-923 capsules administered twice a day over a 10-week period
- Neuropsychiatric Inventory (NPI) [ Time Frame: 10 weeks ]Primary Endpoint: Agitation/Aggression Domain of NPI
- Safety and Tolerability [ Time Frame: 10 weeks ]Standard Measurements (e.g. AEs, ECG, Labs, PE and Neuro Exam)
- Neuropsychiatric Inventory (NPI) [ Time Frame: 10 weeks ]Total NPI
- Neuropsychiatric Inventory (NPI) [ Time Frame: 10 weeks ]Caregiver Distress for NPI Domains
- Neuropsychiatric Inventory (NPI) [ Time Frame: 10 weeks ]NPI-4A (Composite of 4 NPI Domains)
- Neuropsychiatric Inventory (NPI) [ Time Frame: 10 weeks ]NPI-4D (Composite of 4 NPI Domains)
- Neuropsychiatric Inventory (NPI) [ Time Frame: 10 weeks ]Individual Domains of NPI
- ADCS-CGIC (Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change Rating) [ Time Frame: 10 weeks ]Agitation and Overall
- PGIC Patient Global Impression of Change (PGI-C) [ Time Frame: 10 weeks ]Agitation (Rated by Caregiver)
- QoL-AD (Quality of Life - Alzheimer's Disease measure) [ Time Frame: 10 weeks ]
- ADCS-ADL (Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory) [ Time Frame: 10 weeks ]
- CSI (Caregiver Strain Index) [ Time Frame: 10 weeks ]
- CSDD (Cornell Scale for Depression in Dementia) [ Time Frame: 10 weeks ]
- (MMSE) Mini-Mental State Examination [ Time Frame: 10 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01584440
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