ACP-204 for Alzheimer's Disease

Enrolling by invitation at 68 trial locations

Overseen By Mariana Alvarado

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: ACADIA Pharmaceuticals Inc.

Must not be taking: Prohibited medications

Disqualifiers: Hospice care, Bedridden, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the long-term safety of a new treatment called ACP-204 for people with Alzheimer's disease. Participants will take either a 30mg or 60mg dose of this experimental medication. The study targets those who have already completed a previous ACP-204 study and have a caregiver to assist with visits. The researchers aim to assess how well participants tolerate this treatment over a year. Participants should not be in hospice care or require certain restricted medications. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to the development of a promising treatment for Alzheimer's disease.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it excludes those who need treatment with medications that are not allowed by the study protocol.

Is there any evidence suggesting that ACP-204 is likely to be safe for humans?

Research has shown that ACP-204 has been tested for safety in people with Alzheimer's disease psychosis. One study found that it did not significantly affect the QT interval, a measure of heart rhythm, in healthy adults. This suggests ACP-204 is safe for people with Alzheimer's disease. Other studies examined patient tolerance to different doses, such as 30 mg and 60 mg, and found no serious safety issues.

Since this trial is in a later stage, earlier phases generally showed it to be well-tolerated, giving researchers confidence in its safety for longer studies. However, like any treatment, some side effects may occur. Always consult a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Alzheimer's?

ACP-204 is unique because it targets Alzheimer's disease differently than current treatments like donepezil and memantine. Researchers are excited about ACP-204 because it is designed to modulate specific neuronal pathways, potentially offering improved cognitive benefits. Unlike standard treatments that mainly focus on symptomatic relief, ACP-204 aims to address underlying disease processes, which could lead to more effective long-term management of Alzheimer's.

What evidence suggests that ACP-204 might be an effective treatment for Alzheimer's Disease?

Research has shown that ACP-204, which participants in this trial may receive, is being studied for its potential to help people with Alzheimer's disease psychosis. This condition includes challenging symptoms like hallucinations and delusions. In studies, ACP-204 has shown promise in managing these symptoms without affecting heart rhythms, indicating a positive safety profile. While detailed effectiveness data is still being collected, focusing on safety and tolerability remains important for long-term use. The treatment targets brain pathways believed to be involved in these symptoms, which suggests it could be effective. Further studies are ongoing to better understand its full impact on Alzheimer's disease psychosis. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults aged 55 to 95 with Alzheimer's Disease Psychosis who finished the ACP-204-006 study. Participants need a caregiver, must not be pregnant or breastfeeding, and should not have any severe medical conditions that could affect their safety or ability to complete the study.

Inclusion Criteria

Subjects are able to complete all study visits with a study partner/caregiver

Signed inform consent form with a caregiver or legal representative

I am between 55 and 95 years old. If female, I cannot have children. If male, I will use contraception.

Exclusion Criteria

I am not pregnant or breastfeeding.

I do not have any unstable health conditions besides Alzheimer's Disease.

I need to take a medication that is not allowed in this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ACP-204 for long-term safety and tolerability assessment

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ACP-204

Trial Overview The trial is testing the long-term safety and effectiveness of a drug called ACP-204 over a period of one year in patients with Alzheimer's Disease Psychosis who have already completed an initial study.

How Is the Trial Designed?

Group I: ACP-204 Experimental Treatment 1 Intervention

ACP-204 30mg or 60mg

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

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]

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 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 These data include demographics, such as age, sex/gender, race and ethnicity, and study-specific measures (for example, systolic blood pressure, prior ...

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. 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 ( ...

6. 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.