NCT07399171

Study to Evaluate the Effect of HT-4253 for the Prevention of Alzheimer's Disease in APOE4 Carriers

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2a Study to Evaluate the Effect of HT-4253 for the Prevention of Alzheimer's Disease in APOE4 Carriers

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Halia Therapeutics, Inc. · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Primary Objectives: To demonstrate that HT-4253 improves the amyloid risk profile by transitioning biomarker-positive APOE4 carriers from a positive, high risk APS2 score to a negative, low risk APS2 score. Secondary Objectives: * To assess the effects of HT-4253 on tau related blood biomarker progression over the study period. * To assess the effects of HT-4253 on amyloid related blood biomarker progression over the study period. * To assess the safety and tolerability of HT-4253 in the UAE population.

Conditions

• Alzheimers Disease

Interventions

Type	Name	Description
DRUG	HT-4253	It is anticipated that 112 participants will be randomized to receive HT-4253 (56 in each study arm).
OTHER	Placebo	It is anticipated that 112 participants will be randomized to receive placebo (56 in each study arm).

Timeline

• Start date: 2026-04-03
• Primary completion: 2027-05-20
• Completion: 2027-08-20
• First posted: 2026-02-10
• Last updated: 2026-04-17

Locations

1 site across 1 country: United Arab Emirates