A Phase 2a Multicenter, Randomized, Double-Blind, Parallel Group, 26-Week, Placebo-Controlled Study of SUVN-502 in Subjects With Moderate Alzheimer's Disease Currently Treated With Donepezil Hydrochloride and Memantine Hydrochloride
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 564
- 试验地点
- 70
- 主要终点
- Change From Baseline to Week-26 in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11)
研究概览
简要总结
This is a phase 2a, proof-of-concept, 26-week, double-blind, multicenter, randomized, parallel group, placebo-controlled study to compare the efficacy and safety of treatment with SUVN-502 to placebo treatment in subjects with moderate Alzheimer's disease receiving stable doses of donepezil HCl and memantine HCl.
详细描述
This is a phase 2a, proof-of-concept, 26-week, double-blind, multicenter, randomized, parallel group, placebo-controlled study to compare the efficacy and safety of treatment with SUVN-502 to placebo treatment in subjects with moderate Alzheimer's disease receiving donepezil HCl (10 mg qd) and either memantine HCl (10 mg twice daily [bid]) or Namenda XR® (Extended Release, 28 mg qd) or the combination therapy, Namzaric™
The primary objective of the study is to evaluate the efficacy of a serotonin receptor subtype 6 (5-HT6) antagonist, SUVN-502, compared to placebo, as adjunct treatment in subjects with moderate Alzheimer's disease (Mini-Mental State Examination [MMSE] score of 12 to 20) currently treated with the acetylcholinesterase inhibitor, donepezil hydrochloride (HCl), and the N-methyl-D-aspartic acid (NMDA) antagonist, memantine HCl. Efficacy will be assessed by the 11-item Alzheimer's Disease Assessment Scale for Cognitive Behavior (ADAScog-11) after 26 weeks of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a diagnosis of probable Alzheimer's disease based on the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria at least 1 year prior to the screening visit.
- •Has a score between 12 and 20 inclusive on the MMSE at the screening and baseline visits.
- •Has a MRI or CT scan performed within 12 months prior to screening with findings consistent with the diagnosis of dementia due to Alzheimer's disease without any other clinically significant comorbid pathologies.
- •Must be receiving treatment with stable doses of donepezil HCl and memantine HCl for at least 3 months prior to the screening visit
- •Availability of an eligible and reliable caregiver
- •Must be living in the community or an assisted living facility.
- •Must be ambulatory or ambulatory aided (use of cane or walker).
- •Is not pregnant or planning to become pregnant during the study.
- •Subject (or subject's legally acceptable representative) and caregiver must sign an Informed Consent to participate in the study.
排除标准
- •Has a diagnosis of dementia due to other than Alzheimer's Disease
- •Is taking cholinesterase inhibitors other than donepezil HCl or taking doses of donepezil HCl other than 10 mg
- •Is taking doses of memantine HCl other than 10 mg bid or Namenda XR® 28 mg qd.
- •Has uncontrolled cardiac disease or hypertension.
- •Has clinically significant renal or hepatic impairment.
- •Has cancer or a malignant tumor, untreated thyroid disorder or has a history of seizure disorder
- •Is treated or likely to require treatment during the study, with any medications prohibited by the study protocol.
研究组 & 干预措施
Experimental: SUVN-502 Low dose (50 mg)
SUVN-502 Low dose adjunct to base treatment with Donepezil and Memantine
干预措施: SUVN-502 (Drug)
Experimental: SUVN-502 Low dose (50 mg)
SUVN-502 Low dose adjunct to base treatment with Donepezil and Memantine
干预措施: Donepezil (Drug)
Experimental: SUVN-502 Low dose (50 mg)
SUVN-502 Low dose adjunct to base treatment with Donepezil and Memantine
干预措施: Memantine (Drug)
Experimental: SUVN-502 High dose (100 mg)
SUVN-502 High dose adjunct to base treatment with Donepezil and Memantine
干预措施: SUVN-502 (Drug)
Experimental: SUVN-502 High dose (100 mg)
SUVN-502 High dose adjunct to base treatment with Donepezil and Memantine
干预措施: Donepezil (Drug)
Experimental: SUVN-502 High dose (100 mg)
SUVN-502 High dose adjunct to base treatment with Donepezil and Memantine
干预措施: Memantine (Drug)
Placebo
Placebo adjunct to base treatment with Donepezil and Memantine
干预措施: Placebo (Drug)
Placebo
Placebo adjunct to base treatment with Donepezil and Memantine
干预措施: Donepezil (Drug)
Placebo
Placebo adjunct to base treatment with Donepezil and Memantine
干预措施: Memantine (Drug)
结局指标
主要结局
Change From Baseline to Week-26 in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11)
时间窗: Baseline to Week 26
Mean change from baseline at week 26 is assessed for ADAS-Cog11 score. The ADAS-Cog11 is a structured scale that evaluates memory, orientation, attention, reasoning, language, and constructional praxis. ADAS-Cog11 measures cognition by assessing 11 metrics impaired in AD: word recall; commands; constructional praxis; naming objects and fingers; ideational praxis; orientation; word recognition; remembering test instructions; spoken language ability; word-finding difficulty; and comprehension of spoken language. The scale ranges from 0 to 70, with higher scores indicate greater impairment.
次要结局
- Change From Baseline to Week-26 in Change in Mini Mental State Examination (MMSE)(Baseline to Week 26)
- Change From Baseline to Week-26 in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)(Baseline to Week 26)
- Change From Baseline to Week-26 in Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL)(Baseline to Week 26)
- Change From Baseline to Week-26 in Neuropsychiatric Inventory (NPI)(Baseline to Week 26)