AVP-786 in the Treatment of Subjects with Agitation Associatedwith Dementia of the Alzheimer’s Type

Phase 1

• Conditions: Agitation Associated with Dementia of the Alzheimer's Type; MedDRA version: 20.0Level: PTClassification code 10001497Term: AgitationSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-001339-38-HU
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-22
• Last Update Posted: 9 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

1. Diagnosis of probable AD according to the 2011 NIA-AA working
groups criteria.
2. The patient has clinically significant, moderate/severe agitation at the
time of screening and for at least 2 weeks prior to baseline.
3. The diagnosis of agitation must meet the IPA provisional definition of agitation.
4. CGIS-Agitation score is = 4 (moderately ill) at Screening and Baseline.
5. MMSE score between 6 and 26 (inclusive) at Screening and Baseline.
6. Caregiver must be willing and able to comply with study procedures,including not administering any prohibited medications during the course of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 172
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 378

Exclusion Criteria

1. Patient has dementia predominantly of non-Alzheimer's type (e.g.,
vascular dementia, frontotemporal dementia, Parkinson's disease,
substance-induced dementia).
2. Patients with symptoms of agitation that are not secondary to AD
(e.g., secondary to pain, other psychiatric disorder, or delirium).
3. Patients with myasthenia gravis (contraindication for quinidine).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type;Secondary Objective: None;Primary end point(s): Change from Baseline to Week 12 in the composite Cohen-Mansfield<br>Agitation Inventory (CMAI) total score;Timepoint(s) of evaluation of this end point: The CMAI will be assessed at Screening (Day -28 to Day -1),<br>Baseline (Day 1), Day 8 (Visit 2), Day 15 (Visit 2.1), Day 22<br>(Visit 3), Day 43 (Visit 4), Day 64 (Visit 5), Day 85 (Visit 6), and Follow up<br>visit (for ET patients).