NCT06597058

Phase 2 Estimation Study of Fixed Dose Drugs Combination Type of Polypill

A Double-Blind, Placebo-Controlled Phase 2 Estimation Study of Fixed Dose Drugs Combination Type of Polypill Administered to Subjects With Alzheimer's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Noah Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is an estimation-focused Phase 2 study designed to explore and quantify treatment-related changes across multiple clinical outcomes in patients with Alzheimer's disease over a 210-day period. The anticipated study population are males and females aged 50-85 years with very mild to severe Alzheimer's Disease. The duration of individual patient participation will be approximately 224 Days: up to 14 days for Screening, 180 days for study drug administration, and a final follow-up visit at 210 days. The planned study duration is 12-18 months from Screening of the first patient until the last follow-up of the last patients.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	MAR	Once-daily tablet

Timeline

• Start date: 2024-10-16
• Primary completion: 2025-11-05
• Completion: 2025-12-15
• First posted: 2024-09-19
• Last updated: 2026-04-08

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study