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A Study of Fesoterodine and 5-[(1R,5R)-3-Azabicyclo[3.

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at a condition called Alzheimer's Disease Psychosis, which can cause people with Alzheimer's disease to experience hallucinations (seeing or hearing things that are not there) and delusions (believing things that are not true). The treatment being tested is called ML-007C-MA, which is given as a tablet taken by mouth. Some participants will receive ML-007C-MA while others will receive placebo. The purpose of the study is to find out if ML-007C-MA works better than placebo in reducing hallucinations and delusions in people with Alzheimer's disease psychosis and to check if the treatment is safe.

During the study, participants will be randomly assigned to receive either ML-007C-MA or placebo for a treatment period of seven weeks. The maximum daily dose of ML-007C-MA that may be given is 210 milligrams. Participants will need to have a care partner who can provide information about their symptoms and help them follow the study requirements. The care partner must be in regular contact with the participant and will need to attend all study visits with them. Participants must have been living in the same home or care facility for at least six weeks before joining the study and are expected to stay there throughout the study period.

Throughout the study, doctors will measure changes in hallucinations and delusions using rating scales that assess the severity of these symptoms. They will compare scores from the beginning of the study to scores after seven weeks of treatment. The study will also look at whether the treatment helps with other symptoms such as agitation and aggression in some participants, and will measure how much distress caregivers experience related to the participant's hallucinations and delusions. Participants must be between 55 and 90 years old and meet specific criteria related to their Alzheimer's disease diagnosis and the presence of psychotic symptoms for at least two months. A brain scan using MRI or CT must be available or completed during the screening period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and baseline evaluation

    At the beginning of the study, your symptoms will be assessed using a scoring system called NPI-C H+D, which measures hallucinations (seeing or hearing things that are not there) and delusions (false beliefs). This score must be 6 or higher for you to continue in the study.

    Your doctor will evaluate the severity of your hallucinations and delusions using a scale called CGI-S (Clinical Global Impression - Severity). Your score must be 4 or higher, indicating at least moderate symptoms.

    Your cognitive function will be tested using the MMSE (Mini-Mental State Examination), which assesses memory and thinking abilities. Your score should be between 6 and 26.

    A brain scan (either MRI or CT scan) will be reviewed. If you do not have a recent scan from the past 3 years, one will be performed during this screening period.

    Your body mass index (BMI) will be measured to ensure it is at least 18.5.

    If you are taking any medications that are not allowed during the study, these will need to be stopped before you can begin treatment. Your doctor will determine if stopping these medications is appropriate for your health.

    Your care partner will be asked to provide consent to participate in the study, as they will need to accompany you to all visits and help monitor your symptoms and medication compliance.

  2. Step 2

    Randomization and treatment assignment

    You will be randomly assigned to receive either ML-007C-MA (the investigational medication) or placebo (an inactive tablet that looks identical to the medication but contains no active ingredients).

    Neither you nor your doctor will know which treatment you are receiving. This is called a double-blind study design.

    The medication will be provided as a tablet for oral use (taken by mouth).

  3. Step 3

    Treatment period

    You will take the assigned medication daily for 7 weeks.

    The exact dosage and frequency of administration will be determined by the study protocol and your doctor's instructions.

    Your care partner will help ensure that you take the medication as prescribed.

    You will need to attend regular clinic visits during this period so that your doctor can monitor your symptoms and any side effects.

  4. Step 4

    Ongoing assessments during treatment

    Throughout the 7-week treatment period, your symptoms will be regularly assessed using the same scoring systems used at baseline.

    The NPI-C H+D score will continue to measure changes in your hallucinations and delusions.

    The CGI-S score will track the severity of your symptoms over time.

    If you have symptoms of agitation or aggression (measured by a score of 4 or higher on the CGI-S agitation/aggression scale), these symptoms will also be monitored using the NPI-C A+A score.

    Your care partner will be asked about the distress caused by your hallucinations and delusions, as this is also being measured in the study.

    Your doctor will evaluate your overall improvement or worsening using the CGI-C (Clinical Global Impression - Change) scale.

  5. Step 5

    Final assessment at week 7

    At the end of the 7-week treatment period, a final evaluation will be conducted.

    Your NPI-C H+D score will be compared to your baseline score to determine if there has been improvement in your hallucinations and delusions.

    Your CGI-S and CGI-C scores will be recorded to assess the severity and change in your symptoms.

    If applicable, changes in your agitation and aggression symptoms will also be evaluated.

    The distress experienced by your care partner due to your symptoms will be reassessed.

    The study will determine if you are a responder to treatment, which is defined as a reduction of at least 30% in your NPI-C H+D score compared to baseline.

Who can join the trial?

16 criteria

  • You must be between 55 and 90 years old at the time of signing the consent form
  • You must have hallucinations (seeing or hearing things that are not there) and delusions (strong false beliefs) related to Alzheimer's disease
  • You must have had these psychotic symptoms (hallucinations or delusions) for at least 2 months before entering the study
  • You must meet the medical criteria for Possible or Probable Alzheimer's disease based on established guidelines
  • Your score on a test called the MMSE (a test that measures memory and thinking abilities) must be between 6 and 26
  • Your score on a scale that measures the severity of hallucinations and delusions must be 4 or higher at two different visits
  • You must have a specific score on another scale called the NPI-C that shows moderate to severe hallucinations or delusions
  • You must have had a brain scan (either MRI or CT) within the past 3 years after your memory problems started, or be willing to have one done during the screening period
  • Your body mass index (a measure of body weight relative to height) must be 18.5 or higher
  • You must be willing to stop taking certain medications that are not allowed in the study before starting treatment
  • You must have a care partner who sees you regularly, can report on your symptoms, speaks the local language, agrees to attend all study visits with you, and signs a consent form
  • You must be able to communicate well enough to complete study procedures, with help from hearing aids or glasses if needed
  • You must be willing to attend all clinic visits, using a wheelchair or other walking aid if necessary
  • You must have lived at the same home or care facility for at least 6 weeks before the study and plan to stay there throughout the study
  • You must be willing and able to sign a consent form, or if you cannot make this decision yourself, a legally authorized representative (someone legally allowed to make decisions for you) must sign the consent form and you must agree to participate
  • If you are a woman who can become pregnant or a man who is sexually active with a woman who can become pregnant, you must be willing to use birth control during the study and follow restrictions about donating eggs or sperm

Who cannot join the trial?

4 criteria

  • The study information provided does not contain specific exclusion criteria, which are reasons why a patient cannot participate in the clinical trial
  • Without detailed exclusion criteria listed in the source data, it is not possible to provide specific conditions or situations that would prevent participation in this study
  • Typically, exclusion criteria may include things like other medical conditions, certain medications being taken, or specific test results, but these details are not available in the provided information
  • To learn about specific reasons why you might not be able to join this trial, you would need to access the complete study documentation
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Investigated drugs

  • ML-007C-MA

    is an investigational medication being studied for the treatment of hallucinations and delusions in people with Alzheimer's disease psychosis. Hallucinations are when a person sees, hears, or senses things that are not really there, and delusions are false beliefs that a person holds despite evidence to the contrary. This medication is being tested to see if it can help reduce these symptoms in patients with Alzheimer's disease.

  • Placebo

    is an inactive substance that looks like the real medication but contains no active ingredients. It is used in this study to compare against the actual medication to help researchers understand whether the medication being tested is truly effective.

What is already known about the treatment

ML-007C-MA – This is an investigational medication currently being studied in clinical trials for the treatment of hallucinations and delusions that occur in patients with Alzheimer's disease psychosis. The drug is being tested in a controlled research study to determine if it is safe and effective compared to placebo (an inactive treatment). The specific form of administration, how it works in the body at the molecular level, and its exact drug classification have not been publicly disclosed in the available trial information, as the medication is still under investigation and has not yet received approval for general medical use.

Investigated diseases

Alzheimer's Disease Psychosis – Alzheimer's Disease Psychosis is a condition that occurs in people who have Alzheimer's disease and develop additional psychiatric symptoms. The main features of this condition include hallucinations, where a person sees, hears, or senses things that are not really there, and delusions, which are false beliefs that the person holds despite evidence to the contrary. These symptoms appear as Alzheimer's disease progresses and the brain continues to deteriorate. The hallucinations and delusions can cause significant distress to both the person experiencing them and their caregivers. As the underlying Alzheimer's disease worsens over time, these psychotic symptoms may become more frequent or intense. This condition represents a more advanced stage of Alzheimer's disease where cognitive decline is accompanied by changes in perception and thinking.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519820-26-00Protocol codeML-007C-MA-221Estimated enrolment330 patientsSponsorMaplight Therapeutics Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).