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

NCT07399171 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2026-08-05

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Halia Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-12
Primary Completion
2028-02-29
Completion
2028-07-31

Countries

  • United Arab Emirates

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07399171 on ClinicalTrials.gov