Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04464564
• Collaborator: (none)
• Enrollment: 750
• Locations: 76
• Arms: 2
• Anticipated Duration (Months): 51.9
• Patients Per Site: 9.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type.

Condition or Disease	Intervention/Treatment	Phase
Agitation in Patients With Dementia of the Alzheimer's Type	Drug: AVP-786; Drug: Placebo	Phase 3

Detailed Description

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 Design

• Study Type: Interventional
• Anticipated 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: Sep 3, 2020
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AVP-786 Participants will be assigned to treatment with AVP-786 capsules administered twice a day over a 12-week period.	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.	Drug: Placebo; oral capsules

Outcome Measures

Primary Outcome Measures

1. Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score [Baseline; Week 12]

Secondary Outcome Measures

1. Change from Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGI-S) Score, as Related to Agitation [Baseline; Week 12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 90 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Site	Phoenix	Arizona	United States	85004
2	Clinical Research Site	Tucson	Arizona	United States	85719
3	Clinical Research Site	Little Rock	Arkansas	United States	72211
4	Clinical Research Site	Anaheim	California	United States	92805
5	Clinical Research Site	Encino	California	United States	91316
6	Clinical Research Site	Lafayette	California	United States	94549
7	Clinical Research Site	Lomita	California	United States	90717
8	Clinical Research Site	Los Angeles	California	United States	90024
9	Clinical Research Site #840-046	Los Angeles	California	United States	90048
10	Clinical Research Site	Panorama City	California	United States	91402
11	Clinical Research Site	San Diego	California	United States	92128
12	Clinical Research Site	Santa Ana	California	United States	92705
13	Clinical Research Site	Wilmington	Delaware	United States	19801
14	Clinical Research Site	Bradenton	Florida	United States	34205
15	Clinical Research Site #840-066	Coral Springs	Florida	United States	33067
16	Clinical Research Site	Doral	Florida	United States	33166
17	Clinical Research Site	Hallandale Beach	Florida	United States	33009
18	Clinical Research Site	Lady Lake	Florida	United States	32159
19	Clinical Research Site	Miami	Florida	United States	33122
20	Clinical Research Site #840-041	Miami	Florida	United States	33126
21	Clinical Research Site	Miami	Florida	United States	33145
22	Clinical Research Site	Miami	Florida	United States	33176
23	Clinical Research Site	Naples	Florida	United States	34105
24	Clinical Research Site	Pensacola	Florida	United States	32502
25	Clinical Research Site #840-049	West Palm Beach	Florida	United States	33407
26	Clinical Research Site	Winter Park	Florida	United States	32789
27	Clinical Research Site	Atlanta	Georgia	United States	30318
28	Clinical Research Site# 840-061	Honolulu	Hawaii	United States	96817
29	Clinical Research Site	Meridian	Idaho	United States	83646
30	Clinical Research Site	New Bedford	Massachusetts	United States	02740
31	Clinical Research Site	Newton	Massachusetts	United States	02459
32	Clinical Research Site	Bloomfield Township	Michigan	United States	48302
33	Clinical Research Site	O'Fallon	Missouri	United States	63368
34	Clinical Research Site	Las Vegas	Nevada	United States	89128
35	Clinical Research Site	Buffalo	New York	United States	14030
36	Clinical Research Site	Manhasset	New York	United States	11030
37	Clinical Research Site	New Hyde Park	New York	United States	11040
38	Clinical Research Site	Cypress	Texas	United States	77429
39	Clinical Research Site	Dallas	Texas	United States	75206
40	Clinical Research Site	Houston	Texas	United States	77077
41	Clinical Research Site	Alexandria	Virginia	United States	22311
42	Clinical Research Site	Fairfax	Virginia	United States	22031
43	Clinical Research Site #056-003	Leuven		Belgium	3000
44	Clinical Research Site # 056-002	Liège		Belgium	4000
45	Clinical Research Site	Kelowna	British Columbia	Canada	V1Y 1Z9
46	Clinical Research Site	Sarnia	Ontario	Canada	N7T 4X3
47	Clinical Research Site	Montreal	Quebec	Canada	H1M 1B1
48	Clinical Research Site	Quebec City	Quebec	Canada	G3K 2P8
49	Clinical Research Site	Sherbrooke	Quebec	Canada	J1L 0H8
50	Clinical Research Site	Bogota	Columbia	Colombia	111166
51	Clinical Research Site	Pereira	Columbia	Colombia	1111
52	Clinical Research Site	Florida Blanca	Santander	Colombia	111511
53	Clinical Research Site	Bello		Colombia	051050
54	Clinical Research Site	Bogota		Colombia	110231
55	Clinical Research Site	Bogotá		Colombia	110231
56	Clinical Research Site	Gyöngyös	Heves	Hungary	3200
57	Clinical Research Site #1	Budapest		Hungary	1036
58	Clinical Research Site #2	Budapest		Hungary	1036
59	Clinical Research Site #348-004	Zalaegerszeg		Hungary	8900
60	Clinical Research Site #484-006	Monterrey		Mexico	64310
61	Clinical Trial Site #528-001	Amsterdam		Netherlands	1081GN
62	Clinical Research Site	Rimavska Sobota	Sobota	Slovakia	97901
63	Clinical Research Site	Bardejov		Slovakia	08501
64	Clinical Research Site	Trencin		Slovakia	91108
65	Clinical Research Site	Vranov Nad Topľou		Slovakia	09301
66	Clinical Research Site	Begunje na Gorenjskem		Slovenia	4275
67	Clinical Research Site	Ljubljana		Slovenia	1000
68	Clinical Research Site	Ljubljana		Slovenia	1260
69	Clinical Research Site #705-001	Nova Gorica		Slovenia	52905000
70	Clinical Research Site	Oviedo	Asturias	Spain	33011
71	Clinical Research Site #724-010	Burgos		Spain	09006
72	Clinical Research Site # 724-007	Coslada		Spain	28882
73	Clinical Research Site	Madrid		Spain	28006
74	Clinical Research Site	Madrid		Spain	28049
75	Clinical Research Site	Sant Cugat del Vallès		Spain	08195
76	Clinical Research Site	Terrassa		Spain	08222

Sponsors and Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
• ClinicalTrials.gov Identifier: NCT04464564
• Other Study ID Numbers: 20-AVP-786-307; 2020-000799-39
• First Posted: Jul 9, 2020
• Last Update Posted: Aug 24, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.: Agitation; Dementia of the Alzheimer's type; Alzheimer's disease; AVP-786; Deudextromethorphan hydrobromide; Quinidine sulfate
• Additional relevant MeSH terms: Dementia; Alzheimer Disease; Psychomotor Agitation

Study Results

No Results Posted as of Aug 24, 2022