A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease Psychosis

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C H+D) score [Срок оценки: Baseline and End of Treatment (7 weeks)]

Вторичные конечные точки (2)

• Change from Baseline to End of Treatment in the Clinical Global Impressions-Severity (CGI-S) hallucinations and delusions domain-specific score [Срок оценки: 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 [Срок оценки: Baseline and End of Treatment (7 weeks)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 31 центр

• 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
• … и ещё 23 центра

Канада · 4 центра

• Clinical Site — Brampton
• Clinical Site — London
• Clinical Site — Toronto
• Clinical Site — Lévis

Аргентина · 2 центра

• Clinical Site — Córdoba
• Clinical Site — Córdoba

Болгария · 2 центра

• Clinical Site — Pernik
• Clinical Site — Sofia

Чехия · 2 центра

• Clinical Site — Choceň
• Clinical Site — Prague

Венгрия · 2 центра

• Clinical Site — Pécs
• Clinical Site — Pécs

South Korea · 2 центра

• Clinical Site — Daegu
• Clinical Site — Incheon

Франция · 1 центр

• Clinical Site — Toulouse

Италия · 1 центр

• Clinical Site — Roma

Польша · 1 центр

• Clinical Site — Plewiska

Португалия · 1 центр

• Clinical Site — Torres Vedras

Румыния · 1 центр

• Clinical Site — Bucharest

Сербия · 1 центр

• Clinical Site — Kragujevac

Словакия · 1 центр

• Clinical Site — Vranov nad Topľou

Идентификаторы

NCT: NCT06887192 · ML-007C-MA-221 · 2024-519820-26-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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