Study to Evaluate the Effect of HT-4253 for the Prevention of Alzheimer's Disease in APOE4 Carriers (NCT07399171) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Study to Evaluate the Effect of HT-4253 for the Prevention of Alzheimer's Disease in APOE4 Carriers
United Arab Emirates112 participantsStarted 2026-04-03
Plain-language 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.
Who can participate
Age range50 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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).
✓. APOE4 carrier: homozygous (APOE4/APOE4) or heterozygous (APOE3/APOE4), confirmed using the Precivity-ApoE™ test.
✓. Must be ambulatory.
✓. Must be in good health, as determined by the PI, without clinically significant medical history.
✓. Normal physical examination, 12-lead ECG, and vital signs, as determined by the PI.
Exclusion criteria
✕. 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.
✕. Any condition which, in the PI's opinion, puts the participant at significant risk, could confound the study results, or may interfere significantly with the participant's participation in the study.
✕. History of clinically significant unstable psychiatric illness at the PI's discretion (e.g., uncontrolled major depression, uncontrolled schizophrenia, uncontrolled bipolar affective disorder) Note: Well-controlled and stable major depressive disorder or anxiety is permitted.
✕. Prior treatment with an investigational LRRK2 inhibitor or any investigational AD therapy within the 6 months prior to Screening.
✕. Concomitant use of prescription medications primarily indicated for psychiatric disorders or neurodegenerative disease (e.g., antipsychotics, mood stabilizers, investigational agents) within 30 days prior to first dose of study drug (Study Day 1).