Printed from Voxsanity (voxsanity.com.au) — NCT07399171 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Alzheimer's Disease Trial, Recruiting
NCT07399171
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People aged between 50 and 75 years old who have not previously been diagnosed with Alzheimer's disease at the time of signing the consent form.
- People who are able to understand and agree to take part by signing a consent form.
- People with a body mass index (a measure of body weight relative to height) between 18 and 32.
- People whose blood test result using the PrecivityAD2™ test shows a positive amyloid probability score of 47.5 or higher (a score suggesting the possible presence of amyloid, a protein linked to Alzheimer's disease).
- People who carry a specific gene variant called APOE4 — either two copies (homozygous) or one copy (heterozygous) — confirmed by the Precivity-ApoE™ test.
- People who are able to walk and move around independently.
- People who are in good general health, with no significant medical history, as determined by the lead doctor running the trial.
- People with normal results on a physical examination, heart tracing (ECG), and basic health measurements such as blood pressure and heart rate, as determined by the lead doctor.
- Female participants who are either past menopause or have had a surgical procedure that means they cannot become pregnant.
- Male participants who are sexually active with a female partner who could become pregnant must agree to use two forms of contraception during the study and for 30 days after the last dose of the study drug.
- Female participants must have a negative blood pregnancy test at the screening stage.
- People who are able to follow the study procedures in the view of the lead doctor.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who have any medical or neurological condition that the lead doctor considers may be associated with dementia.
- People who have noticed a gradual worsening of their memory over the 6 months before screening.
- People who have previously been diagnosed or are currently diagnosed with Alzheimer's disease, or who score below 26 on a standard memory and thinking test (MoCA).
- People who have any significant condition affecting the brain, heart, lungs, kidneys, digestive system, hormones, breathing, or metabolism — either currently or in their history — that may affect study results, in the lead doctor's opinion.
- People who have any condition that the lead doctor believes puts them at significant risk, could affect the study results, or may seriously interfere with their participation.
- People with a history of significant unstable mental health conditions such as uncontrolled depression, uncontrolled schizophrenia, or uncontrolled bipolar disorder (note: well-controlled and stable depression or anxiety is permitted, confirm with trial site).
- People who have previously been treated with an investigational LRRK2 inhibitor or any investigational Alzheimer's therapy within the 6 months before screening.
- People who have been taking prescription medications primarily used for psychiatric conditions or brain diseases (such as antipsychotics or mood stabilisers) within 30 days before the first dose of the study drug.
- People who have had a mini-stroke, stroke, or any unexplained loss of consciousness within the year before screening.
- People with a known condition affecting the blood vessels of the brain or body.
- People who have had a seizure or convulsion within the 3 years before screening, or who have a progressive brain condition such as Parkinson's disease with dementia, epilepsy with ongoing seizures, normal pressure hydrocephalus, or a recent relapse of multiple sclerosis.
- People who have donated blood or lost more than one unit of blood within 8 weeks before screening, or who plan to donate blood during the study.
- People with poorly controlled diabetes, defined as having had a change in their diabetes medication dosage within 3 months before the first dose of the study drug.
- People with a history of unstable chest pain (angina), heart attack, or chronic heart failure.
- People with chronic, uncontrolled high blood pressure (top number 160 or above, or bottom number 95 or above).
- People who have had a vaccination within 10 days before screening.
- People taking any medications — including prescription drugs, over-the-counter medicines, vitamins, herbal products, or supplements — that the lead doctor believes may increase the risk of side effects or affect the person's ability to complete the study.
- People who have taken another investigational (experimental) drug within 30 days or 5 half-lives before signing the consent form, whichever period is longer (or longer if required by local regulations).
- People who have smoked heavily (more than 10 cigarettes a day or the equivalent in tobacco or nicotine products) within 3 months of screening, or who are unwilling to avoid tobacco and nicotine products for the entire duration of the study.
- People with a history of, or current, substance use disorder, including heavy alcohol use.
- People who are pregnant or breastfeeding.
- People who have abnormal results on laboratory (blood or urine) tests at screening.
- People with a prolonged heart rhythm interval on ECG (above 450 ms for males or above 470 ms for females), unless specifically approved and documented by the lead doctor or a qualified member of the medical team.
- People with reduced kidney function, specifically an estimated filtration rate below 60 mL/min/1.73 m².
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Contact this trial
Phone: 385-355-4315
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Recruiting
Phase
Phase 2
Sponsor
Halia Therapeutics, Inc.
Registry
ClinicalTrials.gov
Start date
12 May 2026
Est. completion
1 February 2028
Where this trial is recruiting
🇦🇪 United Arab Emirates
Primary endpoints
Primary Objective; Primary Endpoint; Primary Endpoint; Primary Endpoint
Can't join this trial?
Data last synced from ClinicalTrials.gov: 18 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.