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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-75
SponsorHalia Therapeutics, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

Participant must be 50-75 years of age, without previous AD diagnosis at the time of signing the informed consent.

Capable of giving signed informed consent.

Body mass index (BMI) between 18 and 32 kg/m2.

A positive amyloid probability score from PrecivityAD2™ test (≥ 47.5).

Disqualifiers

Any medical or neurological condition that in the opinion of the PI may be supportive of dementia.

A history of subjective memory decline with gradual onset and slow progression over the 6 months prior to Screening.

Previous or current diagnosis of AD or mild cognitive decline: MoCA < 26.

Any clinically significant CNS, cardiac, pulmonary, renal, gastrointestinal, endocrinological, respiratory, or metabolic conditions (or history), or other pathological or physiological conditions, that might interfere with the study results in the PI's opinion.

Trial design

Treatments tested in this trial

  • HT-4253
  • Placebo

Treatment groups

112 Participants
are divided into 2 treatment groups

Sponsors and collaborators