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Long‑Term Safety and Tolerability of Oral Fesoterodine in Adults with Hallucinations and Delusions Due to Alzheimer’s Disease Psychosis

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What is this trial about?

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

The study focuses on adults who experience hallucinations and delusions associated with Alzheimer’s disease psychosis. Participants will receive the investigational medication ML-007C-MA, which is taken by mouth as a tablet.

The purpose of the study is to evaluate the long‑term safety and tolerability of the medication. Over several months, participants will take the drug each day and attend regular clinic visits where doctors will check blood work (laboratory tests that look at how the body is functioning), perform an ECG (a quick test that records the heart’s electrical activity), measure vital signs such as blood pressure and weight, and conduct simple memory and thinking assessments to see how cognition changes.

Throughout the trial, any side effects or new health problems will be recorded, and participants may stop the medication if serious issues arise. The overall goal is to determine whether the drug can be used safely for people living with this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline visit

    The participant attends the first study visit after enrollment.

    Clinical staff record medical history, confirm the presence of hallucinations and delusions associated with alzheimer’s disease psychosis, and perform baseline safety tests including blood work, electrocardiogram, vital signs, and weight measurement.

    Cognitive and functional assessments such as the mini-mental state examination, neuropsychiatric inventory, and caregiver burden scale are completed.

  2. Step 2

    Start of study medication

    The participant receives fesoterodine tablets for oral use.

    Each tablet contains 210 mg of the active substance.

    The prescribed dosage, frequency, and total length of treatment are explained; the study focuses on long‑term administration, but specific timing is determined by the study protocol.

  3. Step 3

    Regular follow‑up visits

    The participant returns for scheduled visits throughout the study period.

    At each visit, safety observations are recorded, including any new adverse events, changes in vital signs, weight, and laboratory results.

    The participant continues to take the study medication as directed between visits.

  4. Step 4

    Interim safety and effectiveness assessments

    During follow‑up visits, the participant undergoes repeat cognitive and behavioral assessments to monitor changes in hallucinations, delusions, and overall function.

    Electrocardiograms and additional blood tests are performed to evaluate the safety of ml-007c-ma exposure.

  5. Step 5

    Ongoing long‑term medication administration

    The participant continues daily oral intake of the study medication for the duration of the trial.

    The study is designed to assess safety and tolerability over an extended period; exact end date is defined by the trial schedule.

  6. Step 6

    Final study visit

    At the conclusion of the trial, the participant completes a final assessment of safety labs, cognitive tests, and overall health status.

    All study medication is discontinued according to the protocol, and the participant receives a summary of study findings.

Who can join the trial?

10 criteria

  • You must be willing and able to give written informed consent. If you cannot give consent yourself, your legal representative (called a LAR) must sign the consent and you must give written assent if you are able to do so.
  • You need to have finished the double‑blind treatment period of a previous study that used the same medication (ML‑007C‑MA).
  • The doctor must believe that you could benefit from long‑term open‑label treatment with the medication, meaning you will know you are receiving the drug.
  • You must have a designated study care partner who:
    • is in frequent contact with you so they can accurately report your symptoms and whether you take the study drug,
    • speaks the language used for study assessments, and
    • agrees to take part in study assessments, accompany you to each visit, and sign written consent to participate.
    • You need enough verbal ability to understand and follow study instructions; using hearing aids, reading glasses, a wheelchair, or other mobility aids is allowed.
    • You must live in a stable living environment such as your own home, an assisted‑living residence, or a nursing home, and you are expected to stay there for the whole study.
    • If you are a woman who could become pregnant, or a man who has sexual contact with such a woman, you must agree to follow contraception rules and any sperm/egg donation restrictions. Women are considered not able to become pregnant if they are:
      • postmenopausal – no periods for at least 12 months and a lab test showing FSH levels ≥ 40 mIU/mL, or
      • surgically sterile – having had both ovaries removed, a hysterectomy, or both fallopian tubes removed at least 3 months before starting the study.

Who cannot join the trial?

8 criteria

  • You must not be taking any prohibited medications—drugs that the study has listed as not allowed for participants.
  • If you have developed a new or worsening health problem (called a comorbidity) that could make it unsafe for you to join the study, or that might stop you from following the study rules, you cannot take part.
  • Serious abnormal results from a recent physical exam, blood pressure or other vital sign check, heart test (ECG—a test that records the heart’s electrical activity), or lab tests that could put your safety at risk will exclude you from the study.
  • If you are considered at higher risk for suicidal behavior—for example, because of a past suicide attempt, the doctor’s judgment, or a high score on the GCAS (a scale that measures thoughts about suicide)—you cannot join.
  • A positive pregnancy test or being lactating (producing breast milk) will prevent participation.
  • If you have an allergy or intolerance to the study drug ML-007 or its inactive ingredients (excipients), you are not eligible.
  • You or your main caregiver cannot be an employee or a family member of an employee of MapLight Therapeutics or the study investigators.
  • If the doctor or study sponsor decides you are not appropriate for the study—such as if you did not follow medication rules well in a previous related study—you will be excluded.
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Investigated drugs

fesoterodine is an oral tablet that is being tested in this study to see if it is safe and well‑tolerated when taken for a long time by adults who experience hallucinations and delusions related to Alzheimer’s disease. The medication is given by mouth and is intended to help manage the mental symptoms of the disease while researchers closely monitor any side effects.

What is already known about the treatment

Fesoterodine - The medication is taken by mouth as a tablet, typically 210 mg once daily. It is already approved and widely used for treating an overactive bladder, and now it is being studied in a trial for hallucinations and delusions seen in Alzheimer’s disease psychosis. Fesoterodine works by blocking the chemical messenger acetylcholine at muscarinic receptors, especially the M3 type, which reduces muscle activity in the bladder and may also influence brain signaling. It is classified as an antimuscarinic (muscarinic‑receptor antagonist) drug.

Investigated diseases

Alzheimer's disease psychosis - This condition occurs in people with Alzheimer's disease who begin to see, hear, or sense things that are not real, and hold strong false beliefs. The hallucinations may involve seeing people or objects that are not present, while delusions often center on themes like theft, infidelity, or being harmed. As the underlying Alzheimer's disease advances, these psychotic symptoms can become more frequent and intense. The progression typically follows the overall decline in memory and thinking, with the psychotic features adding to confusion and distress.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521757-16-00Protocol codeML-007C-MA-222Estimated enrolment221 patientsSponsorMaplight Therapeutics Inc.

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