Phase 2
Completed N=564
SUVN-502 With Donepezil and Memantine for the Treatment of Moderate Alzheimer's Disease- Phase 2a Study
Source: ClinicalTrials.gov NCT02580305 ↗Enrolled (actual)
564
Serious AEs
6.5%
Results posted
Jun 2023
Primary outcomePrimary: Change From Baseline to Week-26 in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11) — 2.0; 2.5; 2.6 score on a scale — p=0.41
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week-26 in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11) |
2.0; 2.5; 2.6 | 0.41 |
| SECONDARY Change From Baseline to Week-26 in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) |
1.3; 1.0; 1.2 | 0.46 |
| SECONDARY Change From Baseline to Week-26 in Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL) |
-4.6; -3.4; -4.4 | 0.83 |
| SECONDARY Change From Baseline to Week-26 in Neuropsychiatric Inventory (NPI) |
0.5; 0.4; 2.1 | 0.17 |
| SECONDARY Change From Baseline to Week-26 in Change in Mini Mental State Examination (MMSE) |
-1.1; -1.1; -1.0 | 0.79 |
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.
Data sourced from ClinicalTrials.gov (NCT02580305). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.