SUVN-502 With Donepezil and Memantine for the Treatment of Moderate Alzheimer's Disease- Phase 2a Study
- Conditions
- Alzheimer's Disease
- Interventions
- Registration Number
- NCT02580305
- Lead Sponsor
- Suven Life Sciences Limited
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 564
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental: SUVN-502 Low dose (50 mg) SUVN-502 SUVN-502 Low dose adjunct to base treatment with Donepezil and Memantine Placebo Placebo Placebo adjunct to base treatment with Donepezil and Memantine Experimental: SUVN-502 Low dose (50 mg) Memantine SUVN-502 Low dose adjunct to base treatment with Donepezil and Memantine Placebo Donepezil Placebo adjunct to base treatment with Donepezil and Memantine Experimental: SUVN-502 Low dose (50 mg) Donepezil SUVN-502 Low dose adjunct to base treatment with Donepezil and Memantine Experimental: SUVN-502 High dose (100 mg) Donepezil SUVN-502 High dose adjunct to base treatment with Donepezil and Memantine Experimental: SUVN-502 High dose (100 mg) Memantine SUVN-502 High dose adjunct to base treatment with Donepezil and Memantine Placebo Memantine Placebo adjunct to base treatment with Donepezil and Memantine Experimental: SUVN-502 High dose (100 mg) SUVN-502 SUVN-502 High dose adjunct to base treatment with Donepezil and Memantine
- Primary Outcome Measures
Name Time Method Change From Baseline to Week-26 in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11) 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline to Week-26 in Change in Mini Mental State Examination (MMSE) Baseline to Week 26 Change in Mini-Mental State Examination (MMSE) - Total Score Minimum Score - 0, Maximum Score - 30. Higher score means better outcome.
Change From Baseline to Week-26 in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Baseline to Week 26 Clinical Dementia Rating-Sum of Boxes (CDR-SB) - Sum of Boxes CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care.
Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.Change From Baseline to Week-26 in Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL) Baseline to Week 26 The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score is a 23-item inventory.
The ADCS-ADL measures both basic and instrumental activities of daily living The total ADCS-ADL score ranges from 0 to 78, with lower scores indicating greater disease severity.Change From Baseline to Week-26 in Neuropsychiatric Inventory (NPI) Baseline to Week 26 Neuropsychiatric Inventory (NPI) 12 item - Total Score NPI assesses psychopathology in participants with dementia and other neurologic disorders.
Total score ranges from 12 to 144; higher scores indicate greater disease severity.
Trial Locations
- Locations (70)
Banner Alzheimer's Institute
🇺🇸Phoenix, Arizona, United States
Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
Territory Neurology & Research Institute
🇺🇸Tucson, Arizona, United States
ATP Clinical Research, Inc.
🇺🇸Costa Mesa, California, United States
Neuro-Pain Medical Center Inc
🇺🇸Fresno, California, United States
Neurology Center of North Orange County
🇺🇸Fullerton, California, United States
Senior Clinical Trials, Inc.
🇺🇸Laguna Hills, California, United States
Collaborative Neuroscience Network, LLC
🇺🇸Long Beach, California, United States
Easton Center for Alzheimer's Disease Research at UCLA
🇺🇸Los Angeles, California, United States
Paradigm Research
🇺🇸San Diego, California, United States
Scroll for more (60 remaining)Banner Alzheimer's Institute🇺🇸Phoenix, Arizona, United States