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Phase 2
Age: 50Years - 75Years
All Genders
ID07399171

Phase 2a Study of HT-4253 to Prevent Alzheimers Disease in APOE4 Carriers Aged 50 to 75

Led by Halia Therapeutics, Inc. · Updated on 2026-08-05

112

Participants Needed

3

Research Sites

21 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effect of HT-4253 in preventing Alzheimers disease in adults aged 50 to 75 who carry the APOE4 gene and have a positive amyloid risk profile. The study aims to see if HT-4253 can change this risk to a lower level, as well as assess its impact on tau and amyloid-related blood biomarkers over time. Safety and tolerability of HT-4253 in the UAE population are also being studied. Participants will be randomly assigned to one of two groups one receiving HT-4253 at a dose of 300 mg once daily by mouth, and the other receiving a placebo once daily. After 24 weeks, those in the placebo group will switch to the active treatment. This crossover design allows all participants to receive HT-4253 during the study period. During the 48-week study, participants will undergo regular assessments including blood biomarker tests related to Alzheimers disease progression. Safety monitoring will include physical exams, ECGs, and vital signs. Researchers will measure changes in amyloid risk scores and blood biomarkers at various points to evaluate HT-4253s effects. Participants will be closely followed throughout the duration of the trial to monitor health and treatment response.

CONDITIONS

Brief Title

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

Research Team

A

Associate Medical Director

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