Alzheimers DiseasePhase 2NCT07399171
Study to Evaluate the Effect of HT-4253 for the Prevention of Alzheimer's Disease in APOE4 Carriers
A Phase 2 study testing HT-4253 in people with Alzheimers Disease, run by Halia Therapeutics, Inc. at 3 sites in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Alzheimers Disease
- What is being tested?
- HT-4253
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 3 sitesUnited Arab Emirates
- Study dates
- 12 May 2026to Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- Females must meet one of the following:
- Postmenopausal
- Surgically sterile
- Male participants who are sexually active with a woman of childbearing potential must agree to use a double contraception during the study and for 30 days after the last dose of HT-4253.
- Female participants must have a negative serum pregnancy test (β-human chorionic gonadotropin [β-hCG]) at screening.
- Able to comply with the study procedures in the view of the PI.
Who cannot join
- 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.
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- 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).
- Transient ischemic attack or stroke or any unexplained loss of consciousness (e.g., fainting without a diagnosis) within 1 year prior to Screening.
- Known cerebral or systemic vasculopathy.
- History of seizure or convulsion within 3 years prior to Screening or progressive neurologic disease (Parkinson's with dementia, epilepsy with breakthrough seizures, normal pressure hydrocephalus, multiple sclerosis with recent relapse).
- Have donated blood or had loss of blood of more than a single unit of blood within 8 weeks before Screening or intend to donate blood during the course of the study.
- Poorly controlled diabetes mellitus, as defined by having dosage adjustment of diabetic medication within 3 months prior to first dose of study drug (Study Day 1).
- History of unstable angina, myocardial infarction, and/or chronic heart failure.
- Chronic, uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 95 mmHg).
- Vaccinations within 10 days prior to Screening.
- Use of any medications, including prescription, over the counter (OTC) medications, vitamins, herbal preparations, and supplements, that, in the opinion of the PI, may put the participant at higher risk for AEs, or impair the participant's ability to complete study procedures.
- Use of other investigational drugs at the time of Screening or within 30 days or 5 half-lives prior to signing of the ICF, whichever is longer, or longer if required by local regulations.
- History of heavy smoking (i.e., more than 10 cigarettes a day or the tobacco/nicotine equivalent) within 3 months of Screening or refuse to abstain from tobacco or nicotine-containing products throughout the duration of the study.
- History of, or current substance use disorder, including heavy alcohol use.
- Pregnant or breastfeeding.
- Presence of any laboratory abnormalities at Screening.
- Prolonged QT interval exclusions for QTcF >450 ms for males and >470 ms for females Note: Entry of any participant with an abnormal ECG must be approved and documented by signature of the PI or a medically qualified sub-investigator.
- Impaired renal function with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Arab Emirates3 sites, 3 recruiting
- Recruiting
Burjeel Medical City
Abu Dhabi, Abu Dhabi Emirate
Medical Monitor, 385-355-4315, monitor@haliatx.com
- Not yet recruiting
Sheikh Shakbout Medical City (SSMC)
Abu Dhabi, Abu Dhabi Emirate
Medical Monitor, 385-355-4315, monitor@haliatx.com
- Not yet recruiting
Cleveland Clinic Abu Dhabi
Abu Dhabi
Medical Monitor, 385-355-4315, monitor@haliatx.com
About this study
Official title: 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
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
- Being tested
- HT-4253, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HT-4253Drug
It is anticipated that 112 participants will be randomized to receive HT-4253 (56 in each study arm).
PlaceboOther
It is anticipated that 112 participants will be randomized to receive placebo (56 in each study arm).
| Study group | Role | What they receive |
|---|---|---|
| Study Arm HT-4253 | Active comparator | Arm HT-4253:
HT-4253 (300 mg): dosed once a day, orally (PO QD) Receives: Drug: HT-4253 |
| Study Arm Placebo | Placebo comparator | Arm Placebo:
Placebo: Dosed once a day, orally (PO QD). Participants in this group will switch over to active treatment at week 24. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective
To evaluate that HT-4253 improves the amyloid risk profile by transitioning biomarker-positive APOE4 carriers from a positive, high risk APS2 score to a negative, lower risk APS2 score
Measured: 48 weeks
Primary Endpoint
Proportion of participants demonstrating improvement in amyloid risk profile, as defined by movement from high risk APS2 category (≥ 47.5) at baseline to a lower APS2 category (< 47.5) at week 48, as measured by C2N Diagnostics' PrecivityAD2™ test*
Measured: Week 48
Primary Endpoint
*C2N PrecivityAD2™ Amyloid Probability Score 2 (APS2) Categories:
•Low Risk (< 47.5): Low likelihood of amyloid plaques in the brain, consistent with a negative amyloid Positron Emission Tomography (PET) scan
Measured: Week 48
Primary Endpoint
- High Risk (≥ 47.5): A score within this range suggests that the participant is likely to have amyloid plaques, requiring further diagnostic evaluation
Measured: Week 48
Secondary outcomes (13)
Secondary Objectives
Secondary Objectives:
To evaluate the effects of HT-4253 on tau related blood biomarker progression over the study period
Measured: 12, 24, 36, 48 weeks
Secondary Endpoints
•Change in slope of p-tau217 over 48 weeks.
Measured: 12, 24, 36, 48 weeks
Secondary Endpoints
•Change from baseline in plasma p-tau217 at weeks 12, 24, 36, 48.
Measured: 12, 24, 36, 48 weeks
Secondary Endpoints
•Change from baseline in plasma p-tau181 at week 12, 24, 36, 48.
Measured: 12, 24, 36, 48 weeks
Secondary Objectives
To evaluate the effects of HT-4253 on amyloid related blood biomarker progression over the study period.
Measured: 12, 24, 36, 48 weeks
Secondary Endpoints
- Change from baseline in plasma Aβ42 at weeks 12, 24, 36, 48.
Measured: 12, 24, 36, 48 Weeks
Secondary Endpoints
- Change from baseline in plasma Aβ40 at weeks 12, 24, 36, 48.
Measured: 12, 24, 36, 48 Weeks
Secondary Endpoints
- Change from baseline in plasma Aβ42/ Aβ40 ratio at weeks 12, 24, 36, 48.
Measured: 12, 24, 36, 48 Weeks
Secondary Objectives
To evaluate the safety and tolerability of HT-4253 in the UAE population.
Measured: 12, 24, 36, 48 weeks
Secondary Endpoints
- Incidence and severity of treatment emergent adverse events (TEAEs).
Measured: 12, 24, 36, 48 weeks
Secondary Endpoints
- Incidence of serious adverse events (SAEs).
Measured: 12, 24, 36, 48 weeks
Secondary Endpoints
- Incidence and severity of treatment-related adverse events (TRAEs)
Measured: 12, 24, 36, 48 weeks
Secondary Endpoints
- Incidence of discontinuations due to adverse events (AEs)
Measured: 12, 24, 36, 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start12 May 2026
- Primary completionFeb 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimers DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Halia Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399171
- Sponsor's protocol ID
- HT-4253-APOE-002
- Status last verified
- Apr 2026
- First submitted
- 24 Dec 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07399171
- Acronym / sponsor ID
- HT-4253-APOE-002
- Conditions
- Alzheimers Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Halia Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 May 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Arm HT-4253 | Active comparator | Drug: HT-4253Arm HT-4253: HT-4253 (300 mg): dosed once a day, orally (PO QD) |
| Study Arm Placebo | Placebo comparator | Other: PlaceboArm Placebo: Placebo: Dosed once a day, orally (PO QD). Participants in this group will switch over to active treatment at week 24. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HT-4253It is anticipated that 112 participants will be randomized to receive HT-4253 (56 in each study arm). | Drug | Study Arm HT-4253 |
| PlaceboIt is anticipated that 112 participants will be randomized to receive placebo (56 in each study arm). | Other | Study Arm Placebo |
Primary outcome
Primary Objective
Time frame: 48 weeks
To evaluate that HT-4253 improves the amyloid risk profile by transitioning biomarker-positive APOE4 carriers from a positive, high risk APS2 score to a negative, lower risk APS2 score
Primary Endpoint
Time frame: Week 48
Proportion of participants demonstrating improvement in amyloid risk profile, as defined by movement from high risk APS2 category (≥ 47.5) at baseline to a lower APS2 category (< 47.5) at week 48, as measured by C2N Diagnostics' PrecivityAD2™ test*
Primary Endpoint
Time frame: Week 48
*C2N PrecivityAD2™ Amyloid Probability Score 2 (APS2) Categories: •Low Risk (< 47.5): Low likelihood of amyloid plaques in the brain, consistent with a negative amyloid Positron Emission Tomography (PET) scan
Primary Endpoint
Time frame: Week 48
• High Risk (≥ 47.5): A score within this range suggests that the participant is likely to have amyloid plaques, requiring further diagnostic evaluation
13 secondary outcomes
Secondary Objectives
Time frame: 12, 24, 36, 48 weeks
Secondary Endpoints
Time frame: 12, 24, 36, 48 weeks
Secondary Endpoints
Time frame: 12, 24, 36, 48 weeks
Secondary Endpoints
Time frame: 12, 24, 36, 48 weeks
Secondary Objectives
Time frame: 12, 24, 36, 48 weeks
Secondary Endpoints
Time frame: 12, 24, 36, 48 Weeks
Secondary Endpoints
Time frame: 12, 24, 36, 48 Weeks
Secondary Endpoints
Time frame: 12, 24, 36, 48 Weeks
Secondary Objectives
Time frame: 12, 24, 36, 48 weeks
Secondary Endpoints
Time frame: 12, 24, 36, 48 weeks
Secondary Endpoints
Time frame: 12, 24, 36, 48 weeks
Secondary Endpoints
Time frame: 12, 24, 36, 48 weeks
Secondary Endpoints
Time frame: 12, 24, 36, 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HT-4253 in people with Alzheimers Disease, run by Halia Therapeutics, Inc. at 3 sites in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Associate Medical Director (385-355-4315, monitor@haliatx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective (time frame: 48 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.