ACP-204 for Alzheimer's Disease

Recruiting at 40 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

752 Participants Needed

Trial Summary

What is the purpose of this trial?

This 52-week, open-label extension study is to evaluate the long-term safety and tolerability of ACP-204 in subjects with ADP.

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.

How does the drug ACP-204 differ from other Alzheimer's treatments?

ACP-204 is unique because it may involve a novel approach targeting amyloid-beta peptides, which are linked to Alzheimer's disease. Unlike current treatments that mainly address symptoms, this drug could potentially modify the disease process by affecting amyloid-beta formation or deposition. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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)

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Anti-amnesic effect of ESP-102 on Aβ(1-42)-induced memory impairment in mice. [2010]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Some Candidate Drugs for Pharmacotherapy of Alzheimer's Disease. [2021]

3. Spain pubmed.ncbi.nlm.nih.gov

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

4. Germany pubmed.ncbi.nlm.nih.gov

Amyloid-P-component-like immunoreactivity in beta/A4-immunoreactive deposits in Alzheimer-type dementia brains. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Serum amyloid P component level in Alzheimer's disease. [2019]