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

• Status: Completed
• Trial end date: 2019-11-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Suven Life Sciences Limited
• Treatments: 1-((2-bromophenyl)sulfonyl)-5-methoxy-3-((4-methyl-1-piperazinyl)methyl)-1H-indole dimesylate monohydrate; Donepezil; Memantine

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.