알츠하이머 병 정신병 치료를위한 ML-007C-MA의 효능 및 안전성을 평가하는 연구
알츠하이머 병 정신병과 관련된 환각 및 망상 치료를위한 ML-007C-MA의 효능 및 안전성을 평가하기위한 무작위, 이중 맹검, 위약 대조 연구
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Clinical Trials Contact Center
- 전화번호: +1 650 839 4380
- 이메일: ML-007C-MA-ADP@maplightrx.com
연구 장소
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Daegu, 대한민국, 41404
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Incheon, 대한민국, 21565
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Bucharest, 루마니아, 041914
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Phoenix, Arizona, 미국, 85004
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Scottsdale, Arizona, 미국, 85253
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Tucson, Arizona, 미국, 85704
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California
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Anaheim, California, 미국, 92805
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Long Beach, California, 미국, 90807
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Murrieta, California, 미국, 92562
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Orange, California, 미국, 92866
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San Diego, California, 미국, 92123
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Colorado
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Denver, Colorado, 미국, 80218
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Florida
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Boca Raton, Florida, 미국, 33428
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Deerfield Beach, Florida, 미국, 33442
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Doral, Florida, 미국, 33122
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Homestead, Florida, 미국, 33033
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Miami, Florida, 미국, 33122
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Miami, Florida, 미국, 33155
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Miami, Florida, 미국, 33186
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Miami, Florida, 미국, 33173
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Miami Gardens, Florida, 미국, 33014
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Miami Gardens, Florida, 미국, 33104
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Naples, Florida, 미국, 34105
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Orlando, Florida, 미국, 32807
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Tampa, Florida, 미국, 33629
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West Palm Beach, Florida, 미국, 33407
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Georgia
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Augusta, Georgia, 미국, 30912
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Snellville, Georgia, 미국, 30078
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Louisiana
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Alexandria, Louisiana, 미국, 71301
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Nevada
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Las Vegas, Nevada, 미국, 89121
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West Long Branch, New Jersey, 미국, 07764
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New York, New York, 미국, 10003
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Ohio
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Dayton, Ohio, 미국, 45459
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Independence, Ohio, 미국, 44131
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Oregon
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Tigard, Oregon, 미국, 97223
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South Carolina
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Port Royal, South Carolina, 미국, 29935
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Texas
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Austin, Texas, 미국, 78757
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McKinney, Texas, 미국, 75071
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Sugarland, Texas, 미국, 77478
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Washington
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Bellevue, Washington, 미국, 98007
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Pernik
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Pernik, Pernik, 불가리아, 2304
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Sofia
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Sofia, Sofia, 불가리아, 1408
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Kragujevac, 세르비아, 34000
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Vranov nad Topľou, 슬로바키아, 093 01
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Córdoba, 아르헨티나, X5004AOA
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Buenos Aires F.D.
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Caba, Buenos Aires F.D., 아르헨티나, C1133AAH
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Córdoba Province
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Córdoba, Córdoba Province, 아르헨티나, X5009BIN
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Roma, 이탈리아, 00128
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Choceň, 체코, 565 01
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Prague, 체코, 150 00
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Santiago, 칠레, 7500710
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Santiago, 칠레, 7560359
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Antofagasta, Antofagasta, 칠레, 1240000
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Ontario
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Brampton, Ontario, 캐나다, L6W 2Z8
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London, Ontario, 캐나다, N6A 5W9
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Toronto, Ontario, 캐나다, M4N 3M5
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Quebec
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Lévis, Quebec, 캐나다, G6V 0C9
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Lisbon District
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Torres Vedras, Lisbon District, 포르투갈, 2560-280
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Plewiska, 폴란드, 62-064
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Toulouse, 프랑스, 31059
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Pécs, 헝가리, 7623
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Pécs, 헝가리, 7633
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Key Inclusion Criteria:
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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.
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Meets clinical criteria for Possible AD or Probable AD.
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Presence of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months before Screening.
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Has resided at the same home, residential assisted living, or nursing home facility for a minimum of 6 weeks before Screening.
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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.
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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.
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Has a (CGI)-S hallucinations and delusions domain-specific score ≥4
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Has an Mini-mental State Examination (MMSE) score of 6 to 26, inclusive.
Key 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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: 위약
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Placebo Tablets |
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실험적: ML-007C-MA
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ML-007C-MA dosed as 105/1.5 mg BID, or 210/3 mg BID |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C H+D) score
기간: Baseline and End of Treatment (7 weeks)
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NPI-C H+D scale includes 2 domains from the NPI-C scale, namely, hallucinations and delusions. These 2 domains include the following number of items to be rated by the clinician: Hallucinations, 7 items (maximum score = 21) and Delusions, 8 items (maximum score = 24). The maximum score for the NPI-C: H+D scale is 45. Higher scores on this scale indicate worse outcomes. |
Baseline and End of Treatment (7 weeks)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from Baseline to End of Treatment in the Clinical Global Impressions-Severity (CGI-S) hallucinations and delusions domain-specific score
기간: Baseline and End of Treatment (7 weeks)
|
The CGI-S scale is a clinician-rated, 7-point scale that is designed to rate the severity of the participant's hallucinations and delusions using the investigator's judgment and past experience with participants who have Alzheimer's disease psychosis. Higher scores on this scale indicate worse outcomes. |
Baseline and End of Treatment (7 weeks)
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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
기간: Baseline and End of Treatment (7 weeks)
|
NPI-C A+A scale includes 2 domains from the NPI-C scale, namely, agitation and aggression. These 2 domains include the following number of items to be rated by the clinician: Agitation, 13 items (maximum score = 39), and Aggression, 8 items (maximum score = 24). The maximum score for the NPI-C A+A scale is 63. Higher scores on this scale indicate more severe symptoms of agitation and aggression. |
Baseline and End of Treatment (7 weeks)
|
공동 작업자 및 조사자
수사관
- 연구 책임자: MapLight Therapeutics, MapLight Therapeutics
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- ML-007C-MA-221
- 2024-519820-26-00 (씨티스)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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