SUVN-502 With Donepezil and Memantine for the Treatment of Moderate Alzheimer's Disease- Phase 2a Study

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT02580305

Run by

Suven Life Sciences Limited

People needed

564

Starts

2015-09-01

Expected to finish

2019-11-07

Last updated by the study team

2023-06-09

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Associated Neurologists of South Connecticut — Fairfield, Connecticut, United States
• JEM Research Institute — Atlantis, Florida, United States
• Bradenton Research Center, Inc — Bradenton, Florida, United States
• Brain Matters Research — Delray Beach, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• CCM Clinical Research Group — Miami, Florida, United States
• Collier Neurologic Specialists — Naples, Florida, United States
• Palm Beach Neurological Center — Palm Beach Gardens, Florida, United States
• Anchor Neuroscience — Pensacola, Florida, United States
• Emerald Coast Center for Neurological Disorders — Pensacola, Florida, United States
• Neurostudies Inc — Port Charlotte, Florida, United States
• The Roskamp Institute, Inc. — Sarasota, Florida, United States
• Brain Matters Research — Stuart, Florida, United States
• Neurology Clinical Research, Inc. — Sunrise, Florida, United States
• Axiom Clinical Research of Florida — Tampa, Florida, United States
• Banner Alzheimer's Institute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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