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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Maplight Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Decision date (initial)

2026-05-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

MapLight Therapeutics, Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Diagnosis

To evaluate the safety and tolerability of long-term ML-007C-MA administration in participants with hallucinations and delusions associated with ADP

Secondary objectives 4

1. Safety: To evaluate the safety and tolerability of long-term ML-007C-MA administration in participants with hallucinations and delusions associated with ADP.
2. Effectiveness: To assess the effectiveness of long-term ML-007C-MA administration in adult participants with hallucinations and delusions associated with ADP on the following: • hallucinations and delusions • clinical global impression of the severity of hallucinations and delusions • agitation • cognition • activities of daily living
3. Effectiveness: To evaluate the impact of long-term ML-007C-MA administration on caregiver burden
4. Pharmacokinetic: To characterize the PK of ML-007C-MA in participants with ADP

Conditions and MedDRA coding

Hallucinations and Delusions Associated with Alzheimer’s Disease Psychosis

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 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: a. The participant’s LAR must provide written informed consent. AND b. The participant will provide written (if capable) informed assent.
2. Has completed the Double-Blind Treatment Period of an antecedent study with ML-007C-MA (ie, ML-007-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 meets the following criteria: a. Study care partner is in contact with the participant frequently enough to accurately report on the participant’s symptoms and on participant’s compliance with taking the study drug, in the investigator’s opinion b. Study care partner is fluent in the local language in which the study assessments will be administered. c. Study care partner agrees to participate in study assessments, accompany the participant to each study visit, and provide written consent to participate in the study.
5. Has sufficient verbal ability to satisfactorily comply with study procedures (corrective measures such as hearing aids and reading glasses are allowed, if necessary) and is willing and able to attend clinic visits. Participants who can attend clinic visits using a wheelchair or other ambulatory assistive device are permitted.
6. 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.
7. Women of childbearing potential and men who are sexually active with women of childbearing potential must be willing to adhere to contraception requirements and ova/sperm donation restrictions (Section 13.2). Women must meet 1 of the following criteria to be considered not of childbearing potential: a. Postmenopausal (spontaneous amenorrhea for at least 12 months before dosing without alternative medical explanation) and confirmation by documented FSH levels ≥40 mIU/mL. b. Surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral salpingectomy at least 3 months before dosing).

Exclusion criteria 8

1. Requires treatment with protocol-defined prohibited medications (Table 3)
2. 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 confound the interpretation of the outcome measures in the study.
3. Currently 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 substantially confound the interpretation of the outcome measures in the study in the opinion of the investigator. (Note: Immediate Rollover participants may enter this study before laboratory test values and central ECG reports from the Screening/Baseline Visit (ie, Visit 1E/EOT visit of the antecedent study) are received from the central lab and ECG vendors.)
4. At an elevated risk of suicidal behavior based on 1) investigator judgment, 2) history of suicidal behavior during or since the antecedent study, or 3) GCAS clinician score of 3 or 4 at Screening/Baseline (Immediate Rollovers), or Screening or Baseline Visits (Delayed Rollovers).
5. Positive pregnancy test at Screening/Baseline (Immediate Rollovers), or Screening or Baseline Visits (Delayed Rollovers), or is lactating.
6. Allergy or other intolerance to ML-007 or their excipients.
7. Participant or study care partner is an employee or a family member of an employee of MapLight Therapeutics, Inc. or the investigator/study center.
8. Judged by the investigator or Sponsor to be inappropriate for the study, including participants who were insufficiently adherent to study drug or study drug procedures in the antecedent study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of TEAEs, treatment-emergent SAEs, and TEAEs leading to study discontinuation

Secondary endpoints 4

1. Safety: • Observed values and changes from OL Baseline in clinical safety laboratory assessments, 12-lead ECG parameters, vital sign parameters, and body weight • GCAS score • Changes from OL Baseline in ESRS-A score • Changes from OL Baseline in MMSE score
2. Effectiveness: Changes from OL Baseline in the following: • NPI-C H+D score • CGI-S hallucinations and delusions domain-specific score • NPI-C A+A score in participants who had a CGI-S agitation and aggression domain-specific score of ≥4 at OL Baseline • ADCS-ADL total score
3. Effectiveness: Changes from OL Baseline in ZBI-12 score
4. Pharmacokinetic: Plasma concentrations of ML-007 (and its major metabolites, if applicable)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Maplight Therapeutics Inc.

Sponsor organisation

Maplight Therapeutics Inc.

Address

800 Chesapeake Drive

City

Redwood City

Postcode

94063-4748

Country

United States

Scientific contact point

Organisation

Maplight Therapeutics Inc.

Contact name

to be assigned

Public contact point

Organisation

Maplight Therapeutics Inc.

Contact name

to be assigned

Third parties 15

Locations

9 EU/EEA countries · 24 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 110 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications