ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Acadia Pharmaceuticals Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

4 Dec 2025 → ongoing

Decision date (initial)

2025-11-03

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Acadia Pharmaceuticals Inc.

External identifiers

EU CT number

2025-521710-25-00

ClinicalTrials.gov

NCT07029581

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Dose response, Efficacy

To evaluate efficacy and dose response of ACP-204 30 mg and ACP-204 60 mg compared with placebo in subjects with LBDP (PDDP or DLBP) as measured by the Scale for the Assessment of Positive Symptoms– Lewy Body Dementia Psychosis (SAPS-LBDP), a modified, 9-item scale comprising SAPS Hallucinations and Delusions subscales items

Secondary objectives 3

1. To evaluate efficacy and dose response of ACP-204 30 mg and ACP-204 60 mg compared with placebo in subjects with LBDP (PDDP or DLBPas measured by Clinical Global Impression–Severity in the LBDP context (CGI-S-LBDP)
2. To evaluate efficacy and dose response of ACP-204 30 mg and ACP-204 60 mg compared to placebo in subjects with LBDP (PDDP or DLBP) in the following domains: • symptoms of hallucinations and delusions • sleep disturbance
3. Safety objective To evaluate the safety and tolerability of ACP-204 30 mg and ACP-204 60 mg compared to placebo in subjects with LBDP (PDDP or DLBP)

Conditions and MedDRA coding

Lewy Body Dementia Psychosis (LBDP)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Male or female ≥55 years to <85 years of age at the Screening visit living in the community or, if permitted by local regulations, in an institutionalized setting
2. Can provide written informed consent. If the subject is deemed not competent to provide informed consent, the following requirements for consent must be met: a. The subject’s LAR (or study partner/caregiver, if local regulations allow) must provide written informed consent. b. The subject must provide written (if capable) informed assent per local regulations.
3. Meets either the clinical criteria for Parkinson’s disease with dementia as defined by the Movement Disorder Society’s Task Force or the revised clinical criteria for probable dementia with Lewy bodies (DLB) by consensus criteria (Fourth consensus report of the DLB Consortium)
4. Meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association

Exclusion criteria 5

1. Is in hospice, is receiving end-of-life palliative care, or is bedridden
2. Has psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition (e.g., schizophrenia, bipolar disorder, delusional disorder) other than dementia
3. Is actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline)
4. Has a history or current evidence of a serious and/or significant unstable cardiovascular, respiratory, endocrine, gastrointestinal, renal, hepatic, hematologic, immunologic, genitourinary, psychiatric or neurologic (including stroke, chronic seizures, or clinically significant head injury) abnormality or disease or other medical disorder, including cancer or malignancies, that could interfere with subject’s ability to complete the study or comply with study procedures
5. Has other clinically significant CNS abnormalities that are most likely contributing to the dementia or findings on MRI or CT

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from Baseline in SAPS-LBDP total score at Week 6

Investigational products

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

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Acadia Pharmaceuticals Inc.

Sponsor organisation

Acadia Pharmaceuticals Inc.

Address

12830 El Camino Real Suite 400

City

San Diego

Postcode

92130-2976

Country

United States

Scientific contact point

Organisation

Acadia Pharmaceuticals Inc.

Contact name

Bryan Dirks, Vice President, Clinical Development Lead

Public contact point

Organisation

Acadia Pharmaceuticals Inc.

Contact name

Kristin Kidd, Senior Clinical Study Manager

Third parties 9

Locations

4 EU/EEA countries · 28 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

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

Documents 196 files

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

Application history

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