NCT07417670

Satisfaction With Orodispersible vs Conventional Memantine in Moderate to Severe Alzheimer's Disease

COMPARATIVE STUDY TO EVALUATE SATISFACTION WITH THE USE OF ORODISPERSIBLE MEMANTINE TABLETS VERSUS CONVENTIONAL TABLETS IN PATIENTS WITH MODERATE TO SEVERE ALZHEIMER'S DISEASE: A PHASE IV, RANDOMIZED, OPEN-LABEL STUDY.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Carnot Laboratories · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical study is to evaluate satisfaction with the use of orodispersible Memantine (OD) versus conventional Memantine tablets (MTb) using the validate SATMED-Q in patients with moderate to severe Alzheimer's disease. Due to the neurocognitive impairment associated with these stages of the disease, treatment satisfaction will be assessed indirectly through the primary caregiver. The main questions this study seeks to answer are: * Is caregiver satisfaction higher with OD (Sinolvir®) compared with MTb? * What adverse events or side effects occur in patients receiving memantine in either pharmaceutical form? Researchers will compare OD (Sinolvir®) and MTb to identify differences in caregiver satisfaction and to describe the adverse events reported. Satisfaction will be evaluated across the six domains of the SATMED-Q questionnaire, and results will be summarized by domain and by pharmaceutical dosage form. All adverse events reported during the study will be documented. Participants will receive Sinolvir®(OD) or Eutebrol® (MTb) daily, according to dosing regimens determined by the treating physicians based on the approved prescribing information. The duration of participation will be two months. After two months of treatment, eligible primary caregivers will complete the SATMED-Q questionnaire. Caregivers will be invited to participate at Visit 1 and will complete the satisfaction questionnaire at Visit 2, which will be conducted between days 60 and 70 after Visit 1.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Memantine	orodispersible memantine administered according to a dose titration schedule.
DRUG	Memantine Oral Tablet	Conventional memantine tablets administered according to a dose titration schedule.

Timeline

• Start date: 2024-10-04
• Primary completion: 2025-08-12
• Completion: 2025-08-18
• First posted: 2026-02-18
• Last updated: 2026-02-18

Locations

4 sites across 1 country: Mexico