SUVN-502 With Donepezil and Memantine for the Treatment of Moderate Alzheimer's Disease- Phase 2a Study
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: SUVN-502; Placebo; Donepezil; Memantine
Intervention description: Once-daily, tablets, orally; Once-daily, tablets, orally; Donepezil HCl (10 mg, once a day); Memantine HCl (10 mg, twice a day or 28 mg extended-release, once a day).
Intervention MeSH terms: Memantine; Donepezil; 1-((2-bromophenyl)sulfonyl)-5-methoxy-3-((4-methyl-1-piperazinyl)methyl)-1H-indole dimesylate monohydrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 564.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: SUVN-502; 5-HT6; Phase 2; Cognition; Donepezil; Memantine; Alzheimer's Disease; Triple Combination; Proof of Concept (POC)

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.
    

Eligibility 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.