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 |
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Recruitment Status :
Completed
First Posted : April 25, 2012
Last Update Posted : January 11, 2018
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| 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 |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Arm | Intervention/treatment |
|---|---|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo capsules administered twice a day over a 10-week period |
| Experimental: AVP-923 |
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 ]
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| Ages Eligible for Study: | 50 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Diagnosis of probable Alzheimer's disease (AD).
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.
Either out-patients or residents of an assisted-living facility or a skilled nursing home.
CGI-S score is ≥ 4 (moderately ill) at screening and baseline.
Mini Mental State Examination (MMSE) score at screening between 8 and 28 (inclusive).
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.
Key Exclusion Criteria:
Patient has other type of dementia (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia).
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).
Patients with myasthenia gravis.
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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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Avanir Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01584440 History of Changes |
| Other Study ID Numbers: |
12-AVR-131 |
| First Posted: | April 25, 2012 Key Record Dates |
| Last Update Posted: | January 11, 2018 |
| Last Verified: | January 2018 |
Additional relevant MeSH terms:
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Alzheimer Disease Psychomotor Agitation Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Dyskinesias Neurologic Manifestations Psychomotor Disorders Neurobehavioral Manifestations Signs and Symptoms |
Dextromethorphan Quinidine Quinidine gluconate Antitussive Agents Respiratory System Agents Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Anti-Arrhythmia Agents Antimalarials |