Printed from Voxsanity (voxsanity.com.au) — NCT06177028 — 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, Not Yet Recruiting
NCT06177028
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 who are outpatients (not currently staying in hospital) of either sex.
- People aged 50 to 89 years old at the time of screening.
- Women must have had a surgical procedure to prevent pregnancy (such as tubal ligation, removal of the ovaries, or removal of the uterus), or must have been through menopause for at least 2 years — no women who could become pregnant will be accepted.
- People who have been diagnosed with a mild memory condition called amnestic Mild Cognitive Impairment (MCI), based on specific guidelines, and who score between 22 and 28 on a standard memory test (called the MMSE) at both of their first two study visits.
- People who have had a brain scan (CT or MRI) that fits with the diagnosis and shows no significant damage or other problems that could explain memory difficulties — if no scan has been done in the past 12 months, one must be completed before joining the study.
- People whose vision and hearing are good enough to take part in all study tasks.
- People who are able to swallow tablets or capsules.
- People who score 4 or below on a scale that measures the likelihood that reduced blood flow to the brain is causing memory problems (confirm with trial site).
- People who score 10 or below on a standard depression screening tool for older adults.
- People who are either currently taking stable doses of certain memory medications (cholinesterase inhibitors and/or memantine) — where the dose has been unchanged for at least 90 days before screening and is expected to stay the same throughout the study — or who have tried these medications and were unable to tolerate them or found them ineffective.
- People who have a family member, friend, or carer who spends at least 10 hours per week with them, is willing to come to certain clinic appointments, help supervise taking of study medication, and be available for phone calls as part of the study.
- People who, along with their study partner and legal representative (if they have one), are willing and able to provide signed informed consent as required.
- People who live in the community (not in a care facility) (confirm with trial site).
- People with stable prostate cancer may be considered for inclusion, at the discretion of the study's medical overseer.
- People whose brain amyloid PET scan result is positive, at a specific measurement level (SUVr of 1.05) (confirm with trial site).
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 currently have, or have had in the last 3 years, a neurological or psychiatric condition that could contribute to dementia — such as epilepsy, a focused area of brain damage, Parkinson's disease, seizure disorder, or a head injury that caused loss of consciousness.
- People who meet the criteria for a major psychiatric disorder such as psychosis, severe depression, or bipolar disorder.
- People who are unwilling or unable to have a lumbar puncture (a procedure where a small amount of fluid is collected from around the spine).
- People with a known history of alcohol or drug misuse.
- People who live alone.
- People whose high blood pressure is not well managed.
- People who have had a heart attack, or who have had signs or symptoms of unstable heart disease (including a procedure to open blocked arteries) within the past year.
- People with severe lung disease (including severe COPD) who have needed more than 2 hospital admissions in the past year.
- People with untreated sleep apnea.
- People with any thyroid condition, unless it has been well controlled with treatment for at least 6 months before screening.
- People with an active cancer diagnosis (except for certain non-serious skin cancers) within the past 5 years.
- People with a history of a blood cancer called multiple myeloma.
- People with a very low level of a type of white blood cell (neutrophils below 750/mm³), or a history of this condition.
- People with a current or past history of blood clots, including deep vein thrombosis.
- People with significant liver or kidney disease, including hepatitis B or C, certain elevated liver enzyme levels, or elevated creatinine levels in the blood.
- People with significant blood disorders or clotting problems, including unexplained anaemia or a low platelet count at screening.
- People who have taken part in another drug trial within 30 days before screening, or within five half-lives of that drug — whichever is the longer period.
- People who have used an investigational medical device within two weeks before screening, or who plan to do so before the study ends.
- Women who are of childbearing age or who could become pregnant.
- People who are unwilling or unable to undergo MRI or PET brain scans.
- People who have a cardiac pacemaker, defibrillator, or other implanted device.
- People for whom the study doctor believes participation would not be in their best interest.
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: 602-406-7735
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
Not Yet Recruiting
Phase
Phase 2
Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
Registry
ClinicalTrials.gov
Start date
1 June 2025
Est. completion
2 January 2026
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Primary endpoints
To assess the effect of lenalidomide
Can't join this trial?
Data last synced from ClinicalTrials.gov: 10 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.