NCT07328451招募中1 期
A Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 4
- 主要终点
- Incidence and severity of treatment-emergent adverse events (TEAEs) throughout the double-blind period
研究概览
简要总结
This is a Phase 1b, multicenter, randomized, placebo-controlled, double-blind, multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DNL628 in participants with early Alzheimer's disease (AD), defined as mild cognitive impairment, or mild AD with biomarker evidence of amyloid positivity.
Note: In the Netherlands, this study includes an open-label extension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Sponsor staff directly interacting with the site (clinical operations and medical monitor) will be blinded but may be unblinded if necessary to ensure participant safety.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI of ≥18 to < 32 kg/m2 and body weight of ≥45 kg
- •Have a diagnosis of probable AD dementia based on NIA AA 2011 criteria, including amnestic or nonamnestic presentation at screening
- •Have supportive evidence of AD pathology via historical records or laboratory testing at screening for amyloid positivity
- •Have AD severity defined as the following at screening:
- •A Clinical Dementia Rating global score of 0.5 or 1
- •A Mini-Mental State Examination score of 20 to 30 (inclusive)
排除标准
- •Have clinically significant neurological or cognitive disorders affecting the CNS other than AD, as determined by the investigator
- •Have clinically significant psychiatric conditions
- •Have any history of unstable or poorly controlled endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, hematological, or other significant medical condition that, in the opinion of the investigator, may interfere with the completion or interpretation of study assessment
- •Have had a malignancy within 5 years before screening, except fully resected basal cell carcinoma or other malignancies (such as prostate cancer) at low risk of recurrence, depending on investigator and medical monitor agreement
- •Have had previous anti amyloid or anti tau immunotherapy (including active immunization)
- •Note: ADAD participants who have participated in previous passive anti-amyloid immunotherapy > 6 months previously will be allowed, contingent on investigator and Sponsor agreement
- •Have had previous exposure to gene therapy
研究组 & 干预措施
Experimental Arm
Experimental
干预措施: DNL628 (Drug)
Placebo Arm
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence and severity of treatment-emergent adverse events (TEAEs) throughout the double-blind period
时间窗: 37 weeks
次要结局
- PK Parameter: terminal elimination half-life (t1/2) of DNL628 in plasma(37 weeks)
- Change from baseline in total tau and ptau181 as measured in CSF(25 weeks)
- PK parameter: Maximum concentration (Cmax) of DNL628 in plasma(37 weeks)
- PK Parameter: Time to reach maximum concentration (tmax) of DNL628 in plasma(37 weeks)
- PK Parameter: Minimum concentration (Cmin) of DNL628 in plasma(37 weeks)
- PK Parameter: Area under the concentration-time curve (AUC) from time zero to time of last measurable concentration (AUClast) of DNL628 in plasma(37 weeks)
- PK Parameter: AUC from time 0 to the end of the dosing interval (AUCτ) of DNL628 in plasma(37 weeks)
- PK Parameter: Accumulation ratio of DNL628 in plasma(37 weeks)
研究者
研究点 (4)
Loading locations...
相似试验
招募中
3 期
Study of Oral Deucrictibant XR Tablet for Prophylaxis and Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adults With Acquired Angioedema Due to C1 Inhibitor DeficiencyAcquired Angioedema Due to C1-Inhibitor Deficiency (AAE-C1-INH)NCT07266805Pharvaris Netherlands B.V.48
尚未招募
3 期
A Phase III Study to Evaluate the Efficacy and Safety of MDR-001 in Adult Participants With Overweight or Obesity (MOBILE）Overweight or ObesityNCT07274137MindRank AI Ltd738
终止
2 期
A Clinical Trial of TQH2929 Injection in Patients With Acute Flare-up of Generalized Pustular PsoriasisGeneralized Pustular PsoriasisNCT07314060Chia Tai Tianqing Pharmaceutical Group Co., Ltd.36
招募中
2 期
A Study to Investigate the Clinical Effect and the Safety of PRX-115 Infused Intravenously at Different Dosing Regimens, With and Without Methotrexate, Versus Placebo in Adults Gout Patients (RELEASE)GoutNCT07280156Protalix150
已完成
1 期
A Study to Evaluate the Effect of Single Oral Dose of Balinatunfib on Cardiac Repolarization in Healthy Adult Participants.Cardiac RepolarizationHealthy VolunteersNCT07272629Sanofi48