suvn-502 with donepezil and memantine for the treatment of moderate alzheimer's disease- phase 2a study

Conditions: Alzheimer's Disease

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.

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.

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.

Keywords: suvn-502 5-ht6 phase 2 cognition donepezil memantine alzheimer's disease triple combination proof of concept (poc)