2025-520612-34-00招募中3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated with Alzheimer’s Disease (ADAGIO-2)
Bristol-Myers Squibb Services Unlimited Company34 个研究点 分布在 5 个国家目标入组 90 人开始时间: 2025年10月22日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 34
- 主要终点
- Change from baseline to the end of treatment on the CMAI-IPA total score compared with placebo.
研究概览
简要总结
To demonstrate the efficacy of KarXT + KarX-EC compared with placebo in the treatment of participants with agitation associated with AD as measured by the Cohen-Mansfield Agitation Inventory – International Psychogeriatric Association (CMAI-IPA) scale.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •A diagnosis of Alzheimer’s disease (AD) in accordance with the 2024 Alzheimer’s Association criteria with one of the the following confirmations of AD pathology: - Historical evidence of AD diagnosis with amyloid positron emission tomography (PET), Aβ42/40 ratio in CSF, pTau181/Aβ42 ratio in CSF or pTau217/Aβ42 ratio in plasma using an Health Authority (HA)-authorized diagnostic assay. - If no historical evidence available: A. A plasma biomarker will be assessed for eligibility if allowed per regulatory requirements. The test cutoff(s) will be based on diagnostic use approval. B. If a plasma biomarker assay cannot be used or if the assay result is inconclusive, conduct one the following: o Amyloid PET o Aβ42/40 ratio or pTau181/Aβ42 ratio in CSF using an HA-authorized diagnostic assay
- •Mini-Mental State Examination (MMSE) score of 5 to 22, inclusive, at Screening (Visit 1)
- •Have one identified caregiver who should have sufficient contact (approximately 10 hours a week or more) and is willing to: - Attend all visits and report on participant’s status - Oversee participant compliance with medication and study procedures - Participate in the study assessments and provide IC to participate in the study
- •History of agitation that meets the International Psychogeriatric Association (IPA) consensus definition for agitation in cognitive disorders with onset at least two weeks prior to Screening (Visit 1).
- •AD participants are required to have NPI/NPI-NH Agitation/Aggression score ≥ 4 at Screening (Visit 1) and Baseline (Visit 4).
- •CGI-S ≥ 4, as related to agitation, at Screening (Visit 1) and Baseline (Visit 4)
- •At least 1 of the following 3 criteria must be established from the CMAI-IPA at Screening (Visit 1) and Baseline (Visit 4; CMAI-IPA Physical/Verbal Aggression Positivity): - 1 or more aggressive behaviors occurring several times per week - 2 or more aggressive behaviors occurring once or twice per week - 3 or more aggressive behaviors occurring less than once per week
排除标准
- •Medical Conditions Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia History of bipolar disorder, schizophrenia, or schizoaffective disorder History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator Risk of suicidal behavior during the study as determined by the Investigator’s clinical assessment and/or C-SSR
- •Prior/Concomitant Therapy - Recent history of receiving monoamine oxidase inhibitors, anticonvulsants (eg, lamotrigine, divalproex), mood stabilizers (eg, lithium), tricyclic antidepressants (eg, imipramine, desipramine), or any other psychoactive medications except for as needed anxiolytics (eg, lorazepam) Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors taken at a stable dose for at least 8 weeks prior to Screening (Visit 1) may be permitted Mirtazapine or trazodone may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1)
- •Other protocol-defined Inclusion/Exclusion criteria apply.
结局指标
主要结局
Change from baseline to the end of treatment on the CMAI-IPA total score compared with placebo.
Change from baseline to the end of treatment on the CMAI-IPA total score compared with placebo.
次要结局
- Change from baseline to the end of treatment on the CGI-S as it relates specifically to agitation compared with placebo.
研究者
GSM-CT
Scientific
Bristol-Myers Squibb Services Unlimited Company
研究点 (34)
Loading locations...
相似试验
招募中
2 期
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose ranging Study to Assess the Efficacy and Safety of CDX 0159 in Patients with Chronic Inducible Urticaria2024-516988-87-00Celldex Therapeutics Inc.114
已完成
1 期
A Study to Evaluate the Effect of Single Oral Dose of Balinatunfib on Cardiac Repolarization in Healthy Adult Participants.NCT07272629Sanofi48
进行中（未招募）
2 期
Taldefgrobep Alfa in Adults With Overweight and ObesityObesityNCT07281495Biohaven Therapeutics Ltd.150
已完成
2 期
A study to test whether BI 706321 combined with ustekinumab helps people with Crohn's Disease2024-512756-38-00Boehringer Ingelheim International GmbH27
招募中
2 期
Phase 2 Trial to determine the safety and efficacy of simultaneous treatment with ruxolitinib and extracorporeal photopheresis for patients with steroid-refractory chronic Graft-versus-Host-Disease (SR-cGvHD) - RUX-ECP2023-507754-33-00Medical Center - University Of Freiburg40