ClinicalTrials.gg
Enrolling by invitationNCT07459660Updated Aug 7, 2026

An Open-Label Study of ML-007C-MA in Adults With Alzheimer's Disease Psychosis

A Phase 2 interventional study of ML-007C-MA in Psychosis Associated With Alzheimer's Disease, sponsored by MapLight Therapeutics. Enrolling by invitation at 8 sites in 3 countries. Open to participants aged 55 Years to 91 Years. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by MapLight Therapeutics · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
210
Allocation
Not applicable
Ages
55 Years to 91 Years
Sex
All
01

Study summary

ML-007C-MA-222 is a 52-week, flexible-dose, open-label extension study designed to evaluate the long-term safety, tolerability, and effectiveness of ML007C-MA in participants with ADP who have completed the antecedent study (ie, Study ML-007C-MA-221).

02

Conditions studied

  • Psychosis Associated With Alzheimer's Disease

Keywords

  • Alzheimer Disease
  • Brain Diseases
  • Central Nervous System Diseases
  • Delusions
  • Dementia
  • Hallucinations
  • Mental Disorders
  • Nervous System Diseases
  • Neurocognitive Disorders
  • Neurodegenerative Diseases
  • Psychotic Disorders
  • Schizophrenia Spectrum and Other Psychotic Disorders
  • Tauopathies
  • Muscarinic Antagonists
  • Muscarinic Agonists
  • Cholinergic Agents
03

In context

Alzheimer Disease

3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.

This study's planned enrollment of 210 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

MapLight Therapeutics is the lead sponsor of 6 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 91 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Willing and able to provide written , or, if deemed lacking in the capacity to provide informed consent, the following requirements for consent must be met:

    1. The participant's LAR must provide written informed consent. AND
    2. The participant will provide informed assent.
  2. Has completed the Double-Blind Treatment Period of an antecedent study with ML-007C-MA (ie, ML-007C-MA-221).
  3. May benefit from long-term therapy with open-label ML-007C-MA treatment, in the judgment of the investigator.
  4. Has a designated study care partner who is in contact with the participant frequently enough to accurately report on the participant's symptoms and adherence to study drug.
  5. Resides in a stable living environment (eg, home, residential assisted living, or nursing home facility) and is expected to remain in the living situation throughout the study.

Exclusion criteria

Exclusion Criteria

  1. Under the care of hospice, bed-bound, or receiving end-of-life palliative care.
  2. Requires treatment with protocol-defined prohibited medications.
  3. Has developed a new or worsening medical comorbidity during or since the antecedent study that, in the opinion of the investigator and/or medical monitor, would compromise participant safety, interfere with the participant's ability to comply with study procedures, would preclude obtaining voluntary consent/assent, and/or would substantially impair the evaluation of study assessments.
  4. Has or had a abnormal physical examination, vital sign, or clinical laboratory safety result during or since the antecedent study that would compromise participant safety, interfere with the participant's ability to comply with study procedures, and/or would confound the interpretation of the outcome measures in the study in the opinion of the investigator.
  5. Has developed an allergy or other intolerance to ML-007C-MA, its active ingredients or their since the antecedent study.
  6. Has an elevated risk of suicidal behavior.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
210 participants (estimated)

Study arms

  • Experimental
    ML-007C-MA

    Drug: ML-007C-MA

Interventions

  • ML-007C-MA dosed as 105/1.5 mg BID or 210/3 mg BID

06

What researchers measure

Primary outcomes

  1. To assess the safety and tolerability of long-term ML-007C-MA administration in participants with hallucinations and delusions associated with AD

    using the incidence of TEAEs, TE-SAEs, and TEAEs leading to study discontinuation.

    Time frame: From initial dose through end of treatment (up to 52 weeks)

07

Study locations

8 sites
  • Clinical Site
    Anaheim, California 92805, United States
  • Clinical Site
    Doral, Florida 33122, United States
  • Clinical Site
    Miami, Florida 33155, United States
  • Clinical Site
    Miami, Florida 33173, United States
  • Clinical Site
    Miami Gardens, Florida 33014, United States
  • Clinical Site
    Orlando, Florida 32807, United States
  • Clinical Site
    Pernik, Pernik 2304, Bulgaria
  • Clinical Site
    Toulouse, 31059, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07459660
Lead sponsor
MapLight Therapeutics
Responsible party
Sponsor
First posted
Mar 10, 2026
Start date
Mar 25, 2026
Primary completion
Mar 2029 (estimated)
Completion
Mar 2029 (estimated)
Last update
Aug 7, 2026

Study contacts

MapLight Therapeutics
study director · MapLight Therapeutics

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Studies of the drug tested here: ML-007C

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