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Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia

NCT ID: NCT07284472

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2029-06-30

Brief Summary

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The goal of this clinical trial is to learn if the investigational drugs EXV-802 and EXV-801 can safely and effectively reduce agitation in participants with Alzheimer's Disease Dementia.

Researchers will compare EXV-802 and EXV-801 with a placebo to see if EXV-802 and/or EXV-801 reduces agitation more effectively than the placebo.

Detailed Description

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Conditions

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Agitation Associated With Alzheimer's Disease Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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EXV-802

Group Type EXPERIMENTAL

EXV-802

Intervention Type DRUG

Specified dose twice daily

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Specified dose twice daily

EXV-801

Group Type EXPERIMENTAL

EXV-801

Intervention Type DRUG

Specified dose twice daily

Interventions

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EXV-802

Specified dose twice daily

Intervention Type DRUG

Placebo

Specified dose twice daily

Intervention Type DRUG

EXV-801

Specified dose twice daily

Intervention Type DRUG

Other Intervention Names

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Dextromethorphan + EXV-801

Eligibility Criteria

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Inclusion Criteria

1. The participant is an adult male or female between the ages of 55 to 90 years inclusively, who can move around by themselves, with a walker, or with a wheelchair.
2. A previously established diagnosis of AD dementia.
3. The participant meets definition for agitation which require treatment with medicines.
4. The severity of agitation is at least moderate.

Exclusion Criteria

1. The participant has a confirmed primary diagnosis of a dementia-related disease other than AD dementia.
2. The participant has symptoms of agitation that are due to psychiatric conditions other than AD dementia.
3. The participant has a history of uncontrolled seizures or a history of epilepsy.
4. The participant lacks a caregiver or support person who attends regularly to the participants' needs.
Minimum Eligible Age

55 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Exciva GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2024-517388-22-00

Identifier Type: CTIS

Identifier Source: secondary_id

EXV802-2-1

Identifier Type: -

Identifier Source: org_study_id