ACP-204 for Alzheimer's Disease

Recruiting at 143 trial locations

Overseen By Kristen White

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 2 & 3

Sponsor: ACADIA Pharmaceuticals Inc.

Must be taking: Cholinesterase inhibitors, Memantine

Must not be taking: Anti-tau therapy, Donanemab

Disqualifiers: Hospice care, Atrial fibrillation, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

1074 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ACP-204 for individuals with Alzheimer's disease, a condition that affects memory and thinking. The trial will assess the effectiveness and safety of two different doses of ACP-204 compared to a placebo (a pill with no active medication) in reducing Alzheimer's symptoms. Individuals who have experienced psychotic symptoms (such as hallucinations or delusions) for at least two months and have a stable living situation might be suitable candidates for this trial. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in Alzheimer's treatment.

Do I have to stop taking my current medications for the trial?

The trial requires that you stay on a stable dose of a cholinesterase inhibitor or memantine, if applicable. However, you cannot take certain medications prohibited by the protocol, such as anti-tau therapy or donanemab within 2 months prior to screening.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ACP-204 is generally safe for people. Previous studies found that it does not significantly affect the QT interval, which relates to heart rhythm. This finding suggests that ACP-204 is safe for the heart when used to treat Alzheimer's disease. ACP-204 targets a specific part of the brain to help reduce hallucinations and delusions, with fewer side effects than other treatments. Although all treatments can have side effects, current evidence suggests that ACP-204 is safe for further study in patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ACP-204 for Alzheimer's disease because it offers a potentially novel approach compared to current treatments like cholinesterase inhibitors and memantine. ACP-204 is being tested in two dosages, 30 mg and 60 mg, and is designed to be taken once daily, which could offer convenience for patients. Unlike existing therapies that primarily manage symptoms, ACP-204 might work differently, targeting underlying disease processes to provide more comprehensive benefits. This innovative mechanism of action has sparked interest as it could lead to more effective management of Alzheimer's disease.

What evidence suggests that this trial's treatments could be effective for Alzheimer's Disease?

Research shows that ACP-204 is under investigation for its potential to treat Alzheimer's Disease Psychosis (ADP). Previous studies found that ACP-204 is safe and does not significantly affect heart rhythms, which is promising for treating Alzheimer's-related symptoms. In this trial, participants will receive either a 30 mg or 60 mg dose of ACP-204, or a placebo (a pill with no active drug), to evaluate the effectiveness of these doses. Early studies on the drug's movement through the body are helping to determine the best dosage and understand its effects. Although complete data on its effectiveness is still being gathered, these early results support further research into ACP-204 as a possible treatment for ADP. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 55 to 95 with Alzheimer's Disease Psychosis (ADP), living at home or in a facility, who have a caregiver and are stable on certain dementia medications. They must meet specific criteria for ADP diagnosis, including evidence of amyloid plaque deposition. Excluded are those needing prohibited meds, receiving end-of-life care, having conditions that explain their psychosis other than dementia, or with certain medical exclusions like atrial fibrillation.

Inclusion Criteria

I am between 55 and 95 years old and live at home or in a care facility.

I have been diagnosed with psychosis in a cognitive disorder as per IPA guidelines.

I have experienced symptoms like hallucinations or delusions for at least 2 months.

Exclusion Criteria

On a stable dose of medication?

Have been diagnosed with Alzheimer's Disease?

Are you a male or female and ≥55 and ≤95 years old?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

7 weeks

Treatment

Participants receive ACP-204 30 mg, 60 mg, or placebo once daily for 6 weeks

6 weeks

Safety Follow-up

Participants are monitored for safety after treatment if not entering the open-label extension

4 weeks

Vital Status Follow-up

Monitoring of vital status for participants who terminated their substudy early

Open-label Extension (optional)

Participants may opt into continuation of treatment long-term

What Are the Treatments Tested in This Trial?

Interventions

• ACP-204

Trial Overview

The study tests ACP-204 at two doses (30 mg and 60 mg) against a placebo in three parts: an initial phase to assess efficacy and dose response followed by two confirmatory phases for the chosen doses. Each participant undergoes screening, six weeks of treatment, safety follow-up unless entering an extension study, and vital status updates if leaving early.

How Is the Trial Designed?

Group I: ACP-204 60 mg Experimental Treatment 1 Intervention

Administration once daily at approximately the same time of day, with or without food

Group II: ACP-204 30 mg Experimental Treatment 1 Intervention

Administration once daily at approximately the same time of day, with or without food

Group III: Placebo Placebo Group 1 Intervention

Administration once daily at approximately the same time of day, with or without food

Who Is Running the Clinical Trial?

ACADIA Pharmaceuticals Inc.

Lead Sponsor

Trials

49

Recruited

11,700+

Founded

1993

Headquarters

San Diego, USA

Known For

Neurological Disorders

Top Products

Nuplazid (pimavanserin), Daybue (trofinetide)

Published Research Related to This Trial

Site-directed antibodies targeting beta-amyloid have shown promise in transgenic mice models of Alzheimer's disease by preventing the formation of beta-amyloid and dissolving existing plaques, which helps protect against memory deficits.

Although previous human trials for active immunization with beta-amyloid were halted, new antibody preparations are now in clinical testing, supporting the idea that modulating beta-amyloid could be a viable immunotherapy approach for Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beta-amyloidbased immunotherapy as a treatment of Alzheimers disease. Solomon, B.[2017]

In a study examining the role of amyloid P component in Alzheimer's disease, 90% of senile plaques containing beta/A4 protein also showed positive staining for amyloid P, indicating a strong association between the two.

The results suggest that amyloid P component may play a significant role in the formation of amyloid fibrils within senile plaques in the brains of individuals with Alzheimer-type dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amyloid-P-component-like immunoreactivity in beta/A4-immunoreactive deposits in Alzheimer-type dementia brains. Kimura, M., Arai, H., Takahashi, T., et al.[2019]

In a study comparing serum amyloid P component (AP) levels, patients with Alzheimer's disease (AD) had significantly lower AP levels (22.4 µg/ml) than control subjects (34.4 µg/ml), suggesting a potential biomarker for AD.

The findings indicate that the lower AP production in AD patients may not be due to overproduction of AP in the brain, but rather a suppression of its production by the liver, challenging previous assumptions about its role in Alzheimer's pathology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serum amyloid P component level in Alzheimer's disease. Nishiyama, E., Iwamoto, N., Kimura, M., et al.[2019]

ESP-102 significantly improved memory impairments in mice induced by the amyloid-β (Aβ)(1-42) peptide, as shown by behavioral tests like the passive avoidance and Morris water maze tasks, with a notable effect observed after a single dose of 100 mg/kg.

The mechanism of action for ESP-102 includes inhibition of acetylcholinesterase activity, reduction of lipid peroxidation, and attenuation of inflammatory markers in the hippocampus, suggesting it may protect against neurodegenerative changes associated with Aβ(1-42) exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-amnesic effect of ESP-102 on Aβ(1-42)-induced memory impairment in mice. Kim, DH., Jung, WY., Park, SJ., et al.[2010]

Current treatments for Alzheimer's disease primarily address symptoms rather than the underlying causes, with options like memantine and cholinesterase inhibitors available for cognitive enhancement.

Novel approaches are being explored, including repurposing existing drugs like intranasal insulin and certain antidepressants, which have shown promise in improving cognition and reducing neuropsychiatric symptoms in Alzheimer's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Some Candidate Drugs for Pharmacotherapy of Alzheimer's Disease. Miziak, B., Błaszczyk, B., Czuczwar, SJ.[2021]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06159673

ACP-204 in Adults With Alzheimer's Disease Psychosis

This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in ...

2.

acadia.com

acadia.com/en-us/pdf/healthcare-professionals/scientific-publications/congress-materials/ACP-204_ACCP_2025_Population_PK_Pos_Yamamoto.pdf

Population Pharmacokinetic Modeling

ACP-204 Development Program for Alzheimer's Disease Psychosis: Population Pharmacokinetic Modeling ... Data: Observed ACP-204 Concentration.

3.

neurologylive.com

neurologylive.com/view/alzheimer-psychosis-agent-acp-204-shows-no-impact-corrected-qt-intervals-in-phase-1-analysis

Alzheimer Psychosis Agent ACP-204 Shows No Impact on ...

New findings reveal ACP-204 shows no significant QT interval prolongation in healthy adults, supporting its safety for Alzheimer disease ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S1064748125001289

15. DESIGN OF THE PHASE 2/3, DOUBLE-BLIND ...

ACP-204-006 will be the first clinical study to evaluate the efficacy and safety of ACP-204 in patients with ADP, a population with considerable unmet needs.

5.

clinicaltrials.eu

clinicaltrials.eu/trial/long-term-safety-study-of-acp-204-for-adults-with-alzheimers-disease-psychosis/

Long-Term Safety Study of ACP-204 for Adults ...

This study evaluates the long-term safety of ACP-204, a medication under investigation for the management of Alzheimer's Disease Psychosis symptoms in ...

6.

acadia.com

acadia.com/en-us/media/news-releases/acadia-pharmaceuticals-initiates-phase-2-clinical-trial-acp-204

Acadia Pharmaceuticals Initiates Phase 2 Clinical Trial of ...

A Phase 2 study evaluating the efficacy and safety of ACP-204 for the treatment of hallucinations and delusions associated with Alzheimer's disease psychosis ( ...

7.

ctv.veeva.com

ctv.veeva.com/study/acp-204-in-adults-with-alzheimers-disease-psychosis

ACP-204 in Adults With Alzheimer's Disease Psychosis

Substudy 1 (Phase 2) will evaluate efficacy and dose response of ACP-204 30 and 60 mg vs placebo. This substudy will be initiated first.