Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

Phase 3

Terminated

• Conditions: Agitation in Patients With Dementia of the Alzheimer's Type
• Interventions: Drug: AVP-786

• Registration Number: NCT02446132
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary

This is an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305, which also allows participants from the Phase 2 Study 12-AVR-131 to be included.

Detailed Description

Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305.

Participants will be enrolled in the study for approximately 56 weeks (participants who have a follow-up visit 3 months after the last dose of treatment will be enrolled for approximately 64 weeks).

Approximately 1200 participants will be enrolled at approximately 250 centers globally.

All participants enrolled will receive AVP-786; the treatment dose assigned will be masked to the participant, investigator, study staff, and the sponsor.

Study Timeline

• Study First Submitted: 2015-05-11
• Study First Submitted QC: 2015-05-14
• Study First Posted: 2015-05-18
• Study Start: 2015-12
• Primary Completion: 2024-09-06
• Study Completion: 2024-09-06
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1197

Inclusion Criteria

• Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305. (Note: A delay in enrollment may include delays associated with COVID-19 restrictions.)
• Participants with a diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working group criteria
• Either out-patients or residents of an assisted-living facility or a skilled nursing home
• Participants who delay enrollment must have clinically significant, moderate/severe agitation at least 2 weeks prior to baseline
• Participants who delay enrollment must have a diagnosis of agitation that must meet the International Psychogeriatric Association (IPA) provisional definition of agitation
• Participants who delay enrollment must have a Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation of ≥ 4 (moderately ill) at screening and baseline
• Participants who delay enrollment must have a Mini-Mental State Examination (MMSE) score between 6 and 26 (inclusive) at screening and baseline

Exclusion Criteria

• 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, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
• Participants determined to have a high imminent risk of falls during the study based on a clinical evaluation by the investigator
• Participants who are currently using or were on NUEDEXTA® in the 2 weeks preceding baseline

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AVP-786 (dose 2)	AVP-786	AVP-786 dose 2; capsules administered twice a day over a 52-week period
AVP-786 (dose 1)	AVP-786	AVP-786 dose 1; capsules administered twice a day over a 52-week period
AVP-786 (dose 3)	AVP-786	AVP-786 dose 3; capsules administered twice a day over a 52-week period

Primary Outcome Measures

Name	Time	Method
Number of Participants with any abnormal, clinically significant Physical and Neurological Examination finding	up to 52 weeks
Number of Participants with any abnormal, clinically significant 12-lead Electrocardiogram (ECG) value	up to 52 weeks
Number of Participants with any Treatment-Emergent Adverse Event	up to 64 weeks
Number of participants with any abnormal, clinically significant vital sign value	up to 52 weeks
Change from Baseline to Week 64 in the Sheehan Suicidality Tracking Scale (S-STS) Score	Baseline; Week 64
Number of Participants with any abnormal, clinically significant Clinical Laboratory Value	up to 52 weeks
Change from Baseline to Week 52 in the Mini-Mental State Examination (MMSE) Score	Baseline; Week 52
Change from Baseline to Week 52 in the Epworth Sleepiness Scale (ESS) Score	Baseline; Week 52
Number of Participants with any Treatment-Emergent Serious Adverse Event	up to 64 weeks

Secondary Outcome Measures

Name	Time	Method
Change from Baseline to Week 64 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score	Baseline; Week 64
Change from Baseline to Week 52 in the Agitation/Aggression, Irritability/Lability, and Aberrant Motor Behavior Domain Scores of the Neuropsychiatric Inventory (NPI)	Baseline; Week 52
Change from Baseline to Week 52 in the Resource Utilization in Dementia (RUD) Score	Baseline; Week 52
Change from Baseline to Week 64 in the modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change-Agitation (mADCS-CGIC-Agitation) Score	Baseline; Week 64
Change from Baseline to Week 52 in the Patient Global Impression of Change (PGIC) Score	Baseline; Week 52	PGIC (rated by caregiver)
Change from Baseline to Week 52 in the Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain Score	Baseline; Week 52
Change from Baseline to Week 52 in the Dementia Quality of Life (DEMQOL) Score	Baseline; Week 52
Change from Baseline to Week 52 in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) for Participants from Study 17-AVP-786-305	Baseline; Week 52

Trial Locations

Locations (227)

MD First Research, LLC Site #767; 🇺🇸 Chandler, Arizona, United States

Alliance for Wellness, Inc dba Alliance for Research Site #789; 🇺🇸 Long Beach, California, United States

Central Miami Medical Institute Site #798; 🇺🇸 Miami, Florida, United States

VICIS Clinical Research Inc. Site #777; 🇺🇸 Tampa, Florida, United States

Twoja Przychodnia - Centrum Medyczne Nowa Sol Site #757; 🇵🇱 Nowa Sól, Lubuskie, Poland

RCMed Oddział Sochaczew Site #510; 🇵🇱 Sochaczew, Mazowieckie, Poland

NoesisPharma, LLC; 🇺🇸 Phoenix, Arizona, United States

Perseverance Research Center, LLC; 🇺🇸 Scottsdale, Arizona, United States

Health Initiatives Research; 🇺🇸 Fayetteville, Arkansas, United States

Advanced Research Center, Inc. Site #835; 🇺🇸 Anaheim, California, United States

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