A clinical trial to assess the safety of EXV-802 and EXV-801 and how well they work to reduce agitation symptoms in people with Alzheimer's disease dementia

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Exciva GmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Decision date (initial)

2026-04-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-517388-22-00

ClinicalTrials.gov

NCT07284472

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the therapeutic change from baseline of EXV-802 compared with placebo in the treatment of agitation.

Secondary objectives 7

1. To evaluate the clinical importance of the therapeutic change from baseline of EXV-802 compared with placebo in the treatment of agitation.
2. To evaluate the therapeutic change from baseline of EXV-802 compared with placebo related to caregiver distress due to agitation and aggression.
3. To evaluate the therapeutic change from baseline of EXV-802 compared with placebo related to irritability / lability.
4. To evaluate the therapeutic change from baseline of EXV-802 compared with placebo related to sleep disorders.
5. Safety and tolerability of EXV-802.
6. To evaluate the therapeutic change from baseline of EXV-801 monotherapy compared with placebo.
7. Safety and tolerability of EXV-801 monotherapy.

Conditions and MedDRA coding

Agitation in Alzheimer's Disease Dementia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

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 4

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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Difference between active and placebo as measured by changes from baseline to endpoint (Week 6) in the Cohen-Mansfield Agitation Inventory total score

Secondary endpoints 7

1. EXV-802: Difference between active and placebo as measured by changes from baseline to endpoint (Week 6) in the Clinical Global Impression of Severity of Illness (CGI-S) score, as related to symptoms of agitation.
2. EXV-802: Difference between active and placebo as measured by changes from baseline to endpoint (Week 6) in the NPI-C Caregiver Distress total score for agitation and aggression.
3. EXV-802: Difference between active and placebo as measured by changes from baseline to endpoint (Week 6) in the NPI-C Irritability / Lability score.
4. EXV-802: Difference between active and placebo as measured by changes from baseline to endpoint (Week 6) in the NPI-C Sleep Disorders score.
5. EXV-802: Difference between active and placebo in frequency and severity of adverse events and clinically relevant changes in relevant safety endpoints e.g.: • Mini‐Mental State Examination (MMSE) • Columbia Suicide Severity Rating Scale (C-SSRS) score • Clinical laboratory values • Vital signs • Electrocardiograms (ECGs) • Physical examination findings
6. EXV-801: Difference between active and placebo as measured by changes from baseline to endpoint (Week 6) in CMAI, CGI-S, NPI-C, exploratory PD markers (BDNF), and blood-based biomarkers (analysis limited to descriptive statistics, including the effect size).
7. EXV-801: Difference between active and placebo in frequency and severity of adverse events and clinically relevant changes in relevant safety endpoints e.g.: • Mini‐Mental State Examination (MMSE) • Columbia Suicide Severity Rating Scale (C-SSRS) score • Clinical laboratory values • Vital signs • Electrocardiograms (ECGs) • Physical examination findings

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Exciva GmbH

Sponsor organisation

Exciva GmbH

Address

Hauptstrasse 25, Altstadt Altstadt

City

Heidelberg

Postcode

69117

Country

Germany

Scientific contact point

Organisation

Exciva GmbH

Contact name

Chief Scientific Officer

Public contact point

Organisation

Exciva GmbH

Contact name

Chief Scientific Officer

Third parties 6

Locations

6 EU/EEA countries · 38 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 111 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications