Assessment of the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
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ClinicalTrials.gov Identifier: NCT04408755 |
Recruitment Status :
Recruiting
First Posted : May 29, 2020
Last Update Posted : May 1, 2024
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Condition or disease | Intervention/treatment | Phase |
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Agitation in Patients With Dementia of the Alzheimer's Type | Drug: AVP-786 Drug: Placebo | Phase 3 |
Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD.
This is a multicenter, randomized, double-blind, placebo-controlled study, consisting of 12 weeks of treatment.
Approximately 750 participants will be enrolled at approximately 110 centers worldwide.
Study medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 750 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type |
Actual Study Start Date : | July 8, 2020 |
Estimated Primary Completion Date : | December 31, 2025 |
Estimated Study Completion Date : | March 31, 2026 |
Arm | Intervention/treatment |
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Experimental: AVP-786
Participants will be assigned to treatment with AVP-786 capsules administered twice a day over a 12-week period.
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Drug: AVP-786
oral capsules |
Placebo Comparator: Placebo
Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.
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Drug: Placebo
oral capsules |
- Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score [ Time Frame: Baseline; Week 12 ]
- Change from Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGI-S) Score, as Related to Agitation [ Time Frame: Baseline; Week 12 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participants with a diagnosis of probable Alzheimer's disease according to the 2011 Neuropsychiatric Inventory Agitation/Aggression (NPI-AA) working groups criteria
- Participants with clinically significant, moderate-to-severe agitation for at least 2 weeks prior to Screening that interferes with daily routine per the Investigator's judgment
- Participants who require pharmacotherapy for the treatment of agitation per the Investigator's judgment after an evaluation of reversible factors and a course of nonpharmacological interventions
- Diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation.
- Participants meeting an additional predetermined blinded eligibility criterion, which will remain blinded to the clinical study site Investigators and staff
- Participants with a reliable caregiver who is able and willing to comply with all study procedures, including adherence to administering study drug and not administering any prohibited medications during the course of the study, and who spends a minimum of 2 hours per day for 4 days per week with the participant
Exclusion Criteria:
- Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)
- Participants with symptoms of agitation that are not secondary to Alzheimer's dementia (e.g., secondary to pain, other psychiatric disorder, or delirium)
- Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy [except skin basal-cell carcinoma], poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
- Participants 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): NCT04408755
Contact: Otsuka Call Center | 844-687-8522 | OtsukaRMReconciliation@rmpdc.org |
Responsible Party: | Otsuka Pharmaceutical Development & Commercialization, Inc. |
ClinicalTrials.gov Identifier: | NCT04408755 |
Other Study ID Numbers: |
20-AVP-786-306 2020-000798-26 ( EudraCT Number ) |
First Posted: | May 29, 2020 Key Record Dates |
Last Update Posted: | May 1, 2024 |
Last Verified: | March 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
Time Frame: | Data will be available after marketing approval in global markets or beginning 1-3 years following article publication. There is no end date to the availability of the data. |
Access Criteria: | Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/ |
URL: | https://clinical-trials.otsuka.com |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Agitation Dementia of the Alzheimer's type Alzheimer's disease |
AVP-786 Deudextromethorphan hydrobromide Quinidine sulfate |
Dementia Alzheimer Disease Psychomotor Agitation Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurocognitive Disorders Mental Disorders |
Tauopathies Neurodegenerative Diseases Dyskinesias Neurologic Manifestations Psychomotor Disorders Neurobehavioral Manifestations Aberrant Motor Behavior in Dementia Behavioral Symptoms |