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Acp-204 Tartrate

ACP-204 Tartrate is an investigational drug currently being studied in clinical trials for the treatment of psychosis in adults with Alzheimer’s disease. This article explores the ongoing research, potential benefits, and important information about ACP-204 Tartrate in the context of Alzheimer’s disease psychosis (ADP).

Table of Contents

What is ACP-204?

ACP-204 TARTRATE, also known simply as ACP-204, is a new medication being studied for the treatment of psychosis in adults with Alzheimer’s disease[1]. It is currently undergoing clinical trials to evaluate its safety and effectiveness. ACP-204 is a potent and selective antagonist/inverse agonist of a specific type of serotonin receptor in the brain[1]. This means it blocks or reverses the action of serotonin at certain sites in the brain, which may help reduce psychotic symptoms.

Medical Condition: Alzheimer’s Disease Psychosis

ACP-204 is being developed to treat Alzheimer’s Disease Psychosis (ADP)[1][2]. Alzheimer’s disease is a progressive brain disorder that affects memory, thinking skills, and the ability to carry out simple tasks. Some people with Alzheimer’s also experience psychosis, which can include hallucinations (seeing or hearing things that aren’t there) and delusions (false beliefs). These symptoms can be distressing for both patients and their caregivers.

How ACP-204 Works

ACP-204 targets a specific type of serotonin receptor in the brain called 5-hydroxytryptamine (serotonin) receptor subtype 2A[1]. By blocking or reversing the action of serotonin at these receptors, ACP-204 may help reduce psychotic symptoms in people with Alzheimer’s disease. This approach is different from current antipsychotic medications and may offer a new treatment option for patients.

Clinical Trials

ACP-204 is currently being studied in clinical trials to determine its safety and effectiveness. There are two main studies:

  1. A Phase 2/3 trial evaluating different doses of ACP-204 compared to placebo in adults with Alzheimer’s Disease Psychosis[1].
  2. A 52-week open-label extension study to evaluate the long-term safety and tolerability of ACP-204 in subjects with ADP[2].

These studies aim to determine if ACP-204 can effectively reduce psychotic symptoms and improve overall function in people with Alzheimer’s disease.

Dosage and Administration

In the clinical trials, ACP-204 is being tested at two different doses:

  • 30 mg once daily
  • 60 mg once daily

The medication is given as a capsule and can be taken with or without food[1]. It’s important to note that the optimal dose and administration schedule may change based on the results of these studies.

Eligibility Criteria

To participate in the ACP-204 clinical trials, patients must meet certain criteria. Some key eligibility factors include[1]:

  • Age 55 to 85 years old
  • Diagnosis of Alzheimer’s disease with psychotic symptoms
  • Stable on current Alzheimer’s medications (if applicable)
  • Have a designated caregiver or study partner
  • Meet specific cognitive function criteria (measured by tests like the Mini-Mental State Examination or MMSE)

There are also several exclusion criteria, such as certain medical conditions or medications that might interfere with the study results or pose safety risks[1][2].

Potential Benefits

While the effectiveness of ACP-204 is still being studied, the hope is that it may provide several benefits for people with Alzheimer’s Disease Psychosis:

  • Reduction in psychotic symptoms (hallucinations and delusions)
  • Improved overall function and quality of life
  • A potentially safer alternative to current antipsychotic medications

The clinical trials are measuring these outcomes using specific scales, such as the Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales (SAPS-H+D) and the Clinical Global Impression-Improvement in the ADP context (CGI-I-ADP)[1][2].

Safety Considerations

As with any new medication, safety is a primary concern in the ACP-204 clinical trials. The studies are closely monitoring for any side effects or adverse events. Some specific safety considerations include[1][2]:

  • Monitoring for any changes in physical health, including lab tests
  • Watching for any worsening of Alzheimer’s symptoms
  • Checking for interactions with other medications
  • Long-term safety evaluation in the 52-week extension study

It’s important to note that ACP-204 is still an investigational drug, and its full safety profile is not yet known. Patients and caregivers should discuss any concerns with their healthcare provider and study team.

Aspect Details
Drug Name ACP-204 Tartrate
Condition Studied Alzheimer’s Disease Psychosis (ADP)
Mechanism of Action Potent and selective antagonist/inverse agonist of 5-hydroxytryptamine (serotonin) receptor subtype 2A
Administration Oral capsule, once daily
Dosages Studied 30 mg and 60 mg
Trial Phases Phase 2/3
Trial Duration Initial trial: 6 weeks; Long-term extension: 52 weeks
Primary Outcome Measure Change in SAPS-H+D total score from baseline to Week 6
Key Eligibility Criteria Adults aged 55-85 with Alzheimer’s disease psychosis, MMSE score ≥6 and ≤24, psychotic symptoms for at least 2 months

FAQ

  • What is ACP-204 Tartrate? ACP-204 Tartrate is a potent and selective antagonist/inverse agonist of the 5-hydroxytryptamine (serotonin) receptor subtype 2A. It is being studied as a potential treatment for psychosis in adults with Alzheimer's disease.
  • How is ACP-204 Tartrate administered? ACP-204 Tartrate is administered orally as a capsule, once daily at approximately the same time each day. It can be taken with or without food.
  • What are the dosages being studied in clinical trials? The clinical trials are studying two dosages of ACP-204 Tartrate: 30 mg and 60 mg, both administered once daily.
  • Who is eligible to participate in these clinical trials? Eligible participants are adults aged 55 to 85 years old with Alzheimer's disease psychosis. They must meet specific criteria, including having a designated study partner/caregiver and meeting clinical criteria for possible or probable Alzheimer's disease.
  • How long do the clinical trials for ACP-204 Tartrate last? The initial trial lasts 6 weeks, followed by a safety follow-up period of 30 days. There is also a long-term open-label extension study that lasts 52 weeks to evaluate the safety and tolerability of ACP-204 Tartrate over an extended period.

Ongoing Clinical Trials on Acp-204 Tartrate

  • A Study of ACP-204 Tartrate for Adults With Lewy Body Dementia Psychosis

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia France Italy

  • A Study Testing ACP-204 Tartrate Compared to Placebo for Adults with Lewy Body Dementia Psychosis

    Recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia France Italy

  • Long-Term Safety Study of ACP-204 for Adults with Alzheimer’s Disease Psychosis

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia France Italy Spain

  • Study of ACP-204 for Treating Psychosis in Adults with Alzheimer’s Disease

    Not recruiting

    2 1
    Investigated drugs:
    Bulgaria Czechia France Italy Spain

Glossary

  • Alzheimer's Disease Psychosis (ADP): A condition where individuals with Alzheimer's disease experience psychotic symptoms such as hallucinations and delusions.
  • Antagonist/Inverse Agonist: A type of drug that blocks or reverses the action of a natural substance in the body, in this case, affecting serotonin receptors.
  • 5-hydroxytryptamine (serotonin) receptor subtype 2A: A specific type of serotonin receptor in the brain that ACP-204 Tartrate targets to potentially alleviate psychotic symptoms.
  • Open-Label Extension Study: A type of clinical trial where all participants receive the active drug, and both researchers and participants know what is being administered.
  • MMSE (Mini-Mental State Examination): A test used to measure cognitive impairment in Alzheimer's disease patients.
  • Cholinesterase inhibitor: A type of medication commonly used to treat symptoms of Alzheimer's disease by increasing levels of a brain chemical called acetylcholine.
  • Memantine: A medication used to treat moderate to severe Alzheimer's disease that works by regulating glutamate, a brain chemical involved in learning and memory.
  • Amyloid plaque: Abnormal clusters of protein fragments that build up between nerve cells in the brains of people with Alzheimer's disease.
  • SAPS-H+D (Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales): A clinical tool used to measure the severity of hallucinations and delusions in patients with psychotic disorders.
  • CGI-I-ADP (Clinical Global Impression-Improvement in the ADP context): A scale used to assess the overall improvement of a patient's condition in the context of Alzheimer's Disease Psychosis.

References

  1. http://clinicaltrials.eu/trial/study-of-acp-204-for-treating-psychosis-in-adults-with-alzheimers-disease/
  2. http://clinicaltrials.eu/trial/long-term-safety-study-of-acp-204-for-adults-with-alzheimers-disease-psychosis/