Recruiting NCT06887192
A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease Psychosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ML-007C-MA, Placebo.
- Who it may be relevant to
- Registry conditions: Psychosis Associated With Alzheimer's Disease. Basic parameters: 55 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Bulgaria, Canada, Czechia +9
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis
Overview
ML-007C-MA-221 is a Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ML-007C-MA in male and female participants aged 55 to 90 years with hallucinations and delusions associated with Alzheimer's Disease Psychosis (ADP). The primary objective is to evaluate the efficacy of ML-007C-MA compared with placebo for the treatment of hallucinations and delusions associated with ADP as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.
Interventions
- Drug ML-007C-MA
ML-007C-MA dosed as 105/1.5 mg BID, or 210/3 mg BID - Drug Placebo
Placebo Tablets
Primary outcome measures
- Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C H+D) score [Time frame: Baseline and End of Treatment (7 weeks)]
Secondary outcome measures (2)
- Change from Baseline to End of Treatment in the Clinical Global Impressions-Severity (CGI-S) hallucinations and delusions domain-specific score [Time frame: Baseline and End of Treatment (7 weeks)]
- Change from Baseline to End of Treatment in the Neuropsychiatric Inventory - Clinician Agitation and Aggression (NPI-C A+A) score in participants who have a CGI-S agitation/aggression domain-specific score of ≥4 at Baseline [Time frame: Baseline and End of Treatment (7 weeks)]
Eligibility criteria
Inclusion criteria
- 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.
- Meets clinical criteria for Possible AD or Probable AD.
- Presence of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months before Screening.
- Has resided at the same home, residential assisted living, or nursing home facility for a minimum of 6 weeks before Screening.
- Has a designated care partner who is in contact with the participant frequently enough to accurately report on the participant's symptoms and adherence to study drug.
- Has a NPI-C H+D score of ≥ 6 AND meet at least 1 of the following criteria:
- Moderate to severe delusions, defined as NPI-C Delusions domain score of ≥ 2 on at least 2 of the 8 items OR
- Moderate to severe hallucinations, defined as NPI-C Hallucinations domain score of ≥ 2 on at least 2 of the 7 items.
- Has a (CGI)-S hallucinations and delusions domain-specific score ≥4
- Has an Mini-mental State Examination (MMSE) score of 6 to 26, inclusive.
Exclusion criteria
- Under the care of hospice, bed-bound, or receiving end-of-life palliative care.
- Psychotic symptoms that are primarily attributable to substance abuse or a medical, neurological or psychiatric condition other than Alzheimer's disease.
- Evidence of a CNS disorder other than Alzheimer's disease that is the primary cause of, or a significant contributor to the participant's dementia.
- Moderate or severe major depressive episode within 3 months of Screening, according to DSM-5 criteria.
- Has an elevated risk of suicidal behavior
- Has had an amyloid PET brain scan or CSF Alzheimer's disease biomarker test in the past 3 years with results inconsistent with a diagnosis of AD.
- Evidence of a clinically significant and/or unstable medical condition that, in the opinion of the investigator or medical monitor, could substantially impair cognition, compromise participant safety, interfere with the participant's ability to comply with study procedures or substantially impair the evaluation of efficacy or safety assessments.
- Gastric retention, urinary retention or narrow-angle (angle-closure) glaucoma
- Meets or has met DSM-5 criteria for alcohol or substance use disorder within the past 12 months (excluding caffeine and nicotine).
- Has previously participated in any clinical study with ML-007 or ML-007C-MA.
- Has developed an allergy or other intolerance to ML-007C-MA, its active ingredients or their excipients.
- Received or may have received an investigational drug, biological product or device within 90 days before Baseline (or 6 months for investigational Alzheimer's disease-modifying therapies).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 31 centers
- Clinical Site — Phoenix
- Clinical Site — Scottsdale
- Clinical Site — Tucson
- Clinical Site — Anaheim
- Clinical Site — Murrieta
- Clinical Site — Orange
- Clinical Site — San Diego
- Clinical Site — Denver
- … and 23 more centers
Canada · 4 centers
- Clinical Site — Brampton
- Clinical Site — London
- Clinical Site — Toronto
- Clinical Site — Lévis
Argentina · 2 centers
- Clinical Site — Córdoba
- Clinical Site — Córdoba
Bulgaria · 2 centers
- Clinical Site — Pernik
- Clinical Site — Sofia
Czechia · 2 centers
- Clinical Site — Choceň
- Clinical Site — Prague
Hungary · 2 centers
- Clinical Site — Pécs
- Clinical Site — Pécs
South Korea · 2 centers
- Clinical Site — Daegu
- Clinical Site — Incheon
France · 1 center
- Clinical Site — Toulouse
Italy · 1 center
- Clinical Site — Roma
Poland · 1 center
- Clinical Site — Plewiska
Portugal · 1 center
- Clinical Site — Torres Vedras
Romania · 1 center
- Clinical Site — Bucharest
Serbia · 1 center
- Clinical Site — Kragujevac
Slovakia · 1 center
- Clinical Site — Vranov nad Topľou
Identifiers
NCT: NCT06887192 · ML-007C-MA-221 · 2024-519820-26-00