Psychosis Associated With Alzheimer's DiseasePhase 2NCT07459660
An Open-Label Study of ML-007C-MA in Adults With Alzheimer's Disease Psychosis
A Phase 2 study testing ML-007C-MA in people with Psychosis Associated With Alzheimer's Disease, run by MapLight Therapeutics at 8 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 55 to 91 years
- Conditions the study is for
- Psychosis Associated With Alzheimer's Disease
- What is being tested?
- ML-007C-MA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 25 Mar 2026to Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 91 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent, or, if deemed lacking in the capacity to provide informed consent, the following requirements for consent must be met:
- The participant's LAR must provide written informed consent. AND
- The participant will provide informed assent.
- Has completed the Double-Blind Treatment Period of an antecedent study with ML-007C-MA (ie, ML-007C-MA-221).
- May benefit from long-term therapy with open-label ML-007C-MA treatment, in the judgment of the investigator.
- 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.
- 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.
Who cannot join
- Under the care of hospice, bed-bound, or receiving end-of-life palliative care.
- Requires treatment with protocol-defined prohibited medications.
- 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.
- Has or had a clinically significant abnormal physical examination, vital sign, ECG 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.
- Has developed an allergy or other intolerance to ML-007C-MA, its active ingredients or their excipients since the antecedent study.
- Has an elevated risk of suicidal behavior.
Trial locations and contacts
8 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 3 countries
United States6 sites
Clinical Site
Anaheim, California, 92805
Clinical Site
Doral, Florida, 33122
Clinical Site
Miami, Florida, 33155
Clinical Site
Miami, Florida, 33173
Clinical Site
Miami Gardens, Florida, 33014
Clinical Site
Orlando, Florida, 32807
About this study
Official title: An Open-Label Study to Assess the Long-Term Safety and Tolerability of ML007C-MA in Adult Participants With Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis
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).
- Being tested
- ML-007C-MA
- 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
- Medical subject headings
- Alzheimer Disease, Brain Diseases, Central Nervous System Diseases, Delusions, Dementia, Hallucinations, Mental Disorders, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ML-007C-MADrug
ML-007C-MA dosed as 105/1.5 mg BID or 210/3 mg BID
| Study group | Role | What they receive |
|---|---|---|
| ML-007C-MA | Experimental | Not described Receives: Drug: ML-007C-MA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From initial dose through end of treatment (up to 52 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start25 Mar 2026
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychosis Associated With Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MapLight Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MapLight Therapeutics, Study director, MapLight Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459660
- Sponsor's protocol ID
- ML-007C-MA-222
- Other IDs
- 2025-521757-16-00, 2025
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Assess the Long-Term Safety and Tolerability of ML007C-MA in Adult Participants With Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis
- ClinicalTrials.gov ID
- NCT07459660
- Acronym / sponsor ID
- ML-007C-MA-222
- Keywords
- Alzheimer Disease, Brain Diseases, Central Nervous System Diseases, Delusions, Dementia, Hallucinations, Mental Disorders, Nervous System Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- MapLight TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ML-007C-MA | Experimental | Drug: ML-007C-MA |
Who may qualify
- Ages
- 55 to 91 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Willing and able to provide written informed consent, or, if deemed lacking in the capacity to provide informed consent, the following requirements for consent must be met:
- Has completed the Double-Blind Treatment Period of an antecedent study with ML-007C-MA (ie, ML-007C-MA-221).
- May benefit from long-term therapy with open-label ML-007C-MA treatment, in the judgment of the investigator.
- 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.
- 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.
Key exclusion criteria (6 listed)
- Under the care of hospice, bed-bound, or receiving end-of-life palliative care.
- Requires treatment with protocol-defined prohibited medications.
- 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.
- Has or had a clinically significant abnormal physical examination, vital sign, ECG 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.
- Has developed an allergy or other intolerance to ML-007C-MA, its active ingredients or their excipients since the antecedent study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ML-007C-MAML-007C-MA dosed as 105/1.5 mg BID or 210/3 mg BID | Drug | ML-007C-MA |
Primary outcome
To assess the safety and tolerability of long-term ML-007C-MA administration in participants with hallucinations and delusions associated with AD
Time frame: From initial dose through end of treatment (up to 52 weeks)
using the incidence of TEAEs, TE-SAEs, and TEAEs leading to study discontinuation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MapLight Therapeutics study director
MapLight Therapeutics
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ML-007C-MA in people with Psychosis Associated With Alzheimer's Disease, run by MapLight Therapeutics at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Bulgaria, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and tolerability of long-term ML-007C-MA administration in participants with hallucinations and delusions associated with AD (time frame: From initial dose through end of treatment (up to 52 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.