Assessment of 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: NCT04408755
• Collaborator: (none)
• Enrollment: 750
• Locations: 83
• Arms: 2
• Anticipated Duration (Months): 53.8
• Patients Per Site: 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: Jul 8, 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	Birmingham	Alabama	United States	35294
2	Clinical Research Site #840-013	Little Rock	Arkansas	United States	72205
3	Clinical Research Site	Little Rock	Arkansas	United States	72209
4	Clinical Research Site	Irvine	California	United States	92697
5	Clinical Research Site	La Jolla	California	United States	92093
6	Clinical Research Site	Oceanside	California	United States	92056
7	Clinical Research Site #840-064	Pasadena	California	United States	91105
8	Clinical Research Site	Atlantis	Florida	United States	33462
9	Clinical Research Site	Brandon	Florida	United States	33511
10	Clinical Research Site	Coral Gables	Florida	United States	33134
11	Clinical Research Site	Doral	Florida	United States	33166
12	Clinical Research Site	Jacksonville	Florida	United States	32256
13	Clinical Research Site	Kissimmee	Florida	United States	34744
14	Clinical Research Site #840-069	Maitland	Florida	United States	32751
15	Clinical Research Site	Miami	Florida	United States	33126
16	Clinical Research Site	Miami	Florida	United States	33175
17	Clinical Research Site	Miami	Florida	United States	33176
18	Clinical Research Site	Miami	Florida	United States	33467
19	Clinical Research Site	Orlando	Florida	United States	32819
20	Clinical Research Site	Palm Beach Gardens	Florida	United States	33410
21	Clinical Research Site	Pompano Beach	Florida	United States	33064
22	Clinical Research Site	Tampa	Florida	United States	33609
23	Clinical Research Site	Tampa	Florida	United States	33613
24	Clinical Research Site	Tampa	Florida	United States	33634
25	Clinical Research Site	Newnan	Georgia	United States	30265
26	Clinical Research Site	Honolulu	Hawaii	United States	96817
27	Clinical Research Site	Hattiesburg	Mississippi	United States	39401
28	Clinical Research Site	Mount Arlington	New Jersey	United States	07856
29	Clinical Research Site	West Long Branch	New Jersey	United States	07764
30	Clinical Research Site #840-072	New Windsor	New York	United States	12553
31	Clinical Research Site	Winston-Salem	North Carolina	United States	27157
32	Clinical Research Site	Canton	Ohio	United States	44718
33	Clinical Research Site	Columbus	Ohio	United States	43210
34	Clinical Research Site	Dayton	Ohio	United States	45459
35	Clinical Research Site	Westerville	Ohio	United States	43082
36	Clinical Research Site	Edmond	Oklahoma	United States	73012
37	Clinical Research Site	Oklahoma City	Oklahoma	United States	73106
38	Clinical Research Site	Moosic	Pennsylvania	United States	18507
39	Clinical Research Site	Cordova	Tennessee	United States	38018
40	Clinical Research Site	The Woodlands	Texas	United States	77381
41	Clinical Research Site #025	Richmond	Virginia	United States	23236
42	Clinical Research Site	Plovdiv		Bulgaria	4002
43	Clinical Research Site	Sofia		Bulgaria	1408
44	Clinical Research Site	Varna		Bulgaria	9020
45	Clinical Research Site # 208-001	Aalborg	Region Nordjylland	Denmark	9000
46	Clinical Research Site	Aalborg		Denmark	9000
47	Clinical Research Site #1	Tallinn		Estonia	11315
48	Clinical Research Site #2	Tallinn		Estonia	11315
49	Clinical Research Site	Tartu		Estonia	50406
50	Clinical Research Site	Bad Homburg Vor Der Höhe	Hessen	Germany	61348
51	Clinical Research Site	Mittweida		Germany	09648
52	Clinical Research Site	Munich		Germany	80336
53	Clinical Research Site	Westerstede		Germany	26655
54	Clinical Research Site #300-001	Athens		Greece	11528
55	Clinical Research Site #300-002	Maroúsi		Greece	15123
56	Clinical Research Site #300-003	Thessaloníki		Greece	54645
57	Clinical Research Site	Bydgoszcz	Kujawsko-Pomorskie	Poland	85-023
58	Clinical Research Site	Lublin	Lubelskie	Poland	20-093
59	Clinical Research Site	Bydgoszcz		Poland	85-163
60	Clinical Research Site	Kielce		Poland	25-411
61	Clinical Research Site	Lublin		Poland	20-064
62	Clinical Research Site #616-010	Lublin		Poland	20-080
63	Clinical Research Site	Poznan		Poland	60-369
64	Clinical Research Site	Poznan		Poland	61-853
65	Clinical Research Site	Pruszcz Gdanski		Poland	83-000
66	Clinical Research Site	Siemianowice Śląskie		Poland	41-100
67	Clinical Research Site	Warszawa		Poland	01-737
68	Clinical Research Site	Santa Maria Da Feira	Aveiro	Portugal	4520-211
69	Clinical Research Site	Braga		Portugal	4710-243
70	Clinical Research Site	Matosinhos		Portugal	4520-211
71	Clinical Research Site	Torres Vedras		Portugal	2560-280
72	Clinical Research Site	Bayamon		Puerto Rico	00961
73	Clinical Research Site	San Juan		Puerto Rico	00918
74	Clinical Research Site	Dnipro		Ukraine	49005
75	Clinical Research Site	Kharkiv		Ukraine	61068
76	Clinical Research Site	Kiev		Ukraine	8631
77	Clinical Research Site	Kyiv		Ukraine	04080
78	Clinical Research Site	Lviv		Ukraine	79021
79	Clinical Research Site	Aylesbury		United Kingdom	HP18 0LX
80	Clinical Research Site	Blandford Forum		United Kingdom	DT11 7DD
81	Clinical Research Site	Crowborough		United Kingdom	TN61NY
82	Clinical Research Site	Fulwood		United Kingdom	PR2 9HT
83	Clinical Research Site	Motherwell		United Kingdom	ML1 4UF

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: NCT04408755
• Other Study ID Numbers: 20-AVP-786-306; 2020-000798-26
• First Posted: May 29, 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