Printed from Voxsanity (voxsanity.com.au) — NCT06911944 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 4 Alzheimer's Disease Trial, Not Yet Recruiting
NCT06911944
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
- The person has given their documented agreement to take part in the study procedures.
- The person is between 35 and 50 years of age (inclusive).
- Blood test results at screening show a protein level (phosphorylated tau 217) consistent with what is required for amyloid brain scan eligibility.
- The person has a confirmed diagnosis of Down syndrome (including trisomy 21, mosaic trisomy 21, Robertsonian translocation trisomy 21, or partial trisomy 21), confirmed through medical records or genetic testing.
- The person has an IQ score of 40 or higher, as measured by a specific standardised intelligence test (Kaufman Brief Intelligence Test, Second Edition).
- The person is in good general health based on their medical history and has not been diagnosed with dementia.
- Brain scan results at screening show elevated amyloid levels (above 18 centiloids).
- Any permitted medications have been taken at a stable dose for at least 4 weeks before screening.
- In the trial site doctor's opinion, the person has a study partner who is able and willing to provide accurate information about them, attend study visits, and complete assessments — typically requiring at least 5 hours of contact with the participant per week throughout the study.
- In the trial site doctor's opinion, the person is likely to be able to follow the study requirements for its full duration, and has adequate vision, hearing (hearing aids are permitted), and literacy to complete the required tests.
- The person must complete all screening assessments as outlined in the study protocol.
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.
- Women who are breastfeeding or pregnant at screening, or who plan to become pregnant during the study.
- Women who could become pregnant, or men whose female partner could become pregnant, where a highly effective contraception method combined with a barrier method (such as a condom) was not used in the 28 days before screening, or where both methods are not intended to be used throughout the study and for 3 months after the last dose of study drug.
- People who weigh less than 40 kilograms at screening.
- People whose veins are not suitable for intravenous drug delivery or repeated blood draws.
- People with known or suspected allergic or hypersensitivity reactions to humanised monoclonal antibodies or any ingredient in the study treatments (donanemab or placebo).
- People who have previously been treated with donanemab, unless there is clear evidence they received only the placebo.
- People who are currently taking or have previously taken a medication listed as prohibited in the study protocol.
- People who are currently enrolled in another clinical study, or who have taken an investigational drug within 30 days before screening, or within five half-lives of that drug — whichever is longer.
- People whose MRI scan at screening shows certain brain abnormalities, including a single area of fluid build-up (vasogenic edema), superficial bleeding on the brain surface, signs of a previous large brain bleed, more than one confirmed small brain bleed, space-occupying lesions, more than two small stroke-related areas (lacunar infarcts), one stroke-related area larger than 1 cm, severe white matter disease, or brain changes not consistent with Alzheimer's disease that may explain the person's symptoms. (Note: small, incidental meningiomas and fluid-filled cysts smaller than 1 cm may be permitted following review and approval by the Medical Monitor.)
- People who cannot have an MRI scan due to metal implants, a pacemaker or other MRI-incompatible devices, or severe claustrophobia.
- People for whom amyloid PET brain imaging or the use of the imaging agent florbetapir is not suitable.
- People with an unstable or clinically significant medical condition that could interfere with assessing how safe or effective the study drug is — for example, moderate or severe untreated sleep apnea, significantly low vitamin B12 or folate levels, significant thyroid problems, stroke, or other brain blood vessel conditions — as determined by the trial site doctor.
- People with a history of severe allergic reactions (such as anaphylaxis), including to vaccines, foods, or medications.
- People who were hospitalised within 30 days before screening or before the study start (baseline).
- People who had a significant infection or major surgery within 3 months before screening.
- People with a history of ongoing or recurring infections that the trial site doctor considers clinically significant and that could affect the evaluation of the study.
- People who had a heart attack within the past year, who have unstable chest pain (angina), or who have significant coronary artery disease.
- People with a history of cancer in the past 5 years, except for certain fully treated and considered-cured skin or localised cancers (treated squamous cell carcinoma, basal cell carcinoma, melanoma in-situ, in-situ prostate cancer, or in-situ breast cancer).
- People with a history or current presence of immune system or inflammatory conditions, including neurological disorders, considered clinically significant by the trial site doctor.
- People with a history of meningitis or meningoencephalitis (infections causing brain or surrounding tissue inflammation).
- People with a history of moderate or severe traumatic brain injury.
- People with uncontrolled seizures; if a person has a history of seizures, they must have been well controlled with no seizures in the 2 years before screening (anti-seizure medications are permitted).
- People with a current or past psychiatric or neurological condition — such as a serious head injury with loss of consciousness, stroke with symptoms, Parkinson's disease, severe narrowing of neck arteries, mini-strokes, or brain bleeds — unless these are considered related to Alzheimer's disease.
- People who have met the clinical criteria for drug or alcohol abuse or dependence within the past 5 years.
- People assessed as having a significant risk of suicide, defined as answering "yes" to certain suicidal thought or behaviour questions on a specific standardised scale (Columbia-Suicide Severity Rating Scale, Child Version) within the past 12 months.
- People with significantly abnormal vital signs, including a sustained sitting blood pressure above 160/90 mmHg.
- People with diabetes who have a blood sugar control measure (HbA1c) of 8.0% or higher.
- People with clinically significant abnormalities in blood counts, liver function tests, or other blood measures, as determined by the trial site doctor.
- People with a known history of HIV (types 1 and 2).
- People with a known history of acute or chronic hepatitis B or C.
- People with clinically significant irregular heart rhythms or other significant abnormalities on a heart tracing (ECG) at screening (minor abnormalities confirmed as insignificant by the trial site doctor are permitted).
- People who live in a continuous care nursing facility.
- For people taking part in an optional sub-study involving spinal fluid collection (lumbar puncture), people for whom a lumbar puncture is not suitable — including those who cannot tolerate the required position, have abnormal blood clotting results, have a low platelet count (below 120,000/μL), have an infection at the puncture site, are taking blood-thinning medications within 90 days of the procedure (note: low-dose aspirin up to 81 mg is permitted), have severe arthritis of the lower spine, suspected or known fluid pressure problems in the brain, or a prior history of spinal mass or injury.
- People who are unwilling to be told their APOE genetic type and/or their amyloid PET scan results.
- People who carry two copies of the APOE ε4 gene variant (known as APOE ε4 homozygotes).
- People who have received blood-thinning medications (anticoagulants or thrombolytics) within 30 days before the study start; use of these medications during the study will result in stopping the study drug.
- People with blood clotting disorders.
- People considered unsuitable for inclusion by the trial site doctor, coordinating centre, regulatory sponsor, or study leadership.
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.
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.
If you need support right now
This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.
If you or someone else is in immediate danger, call 000.
- Lifeline — 24/7 crisis support: 13 11 14
- Suicide Call Back Service — 24/7 counselling: 1300 659 467
- 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
- Beyond Blue — 24/7 mental health support: 1300 22 4636
- Kids Helpline — 24/7, free and private for anyone aged 5 to 25: 1800 55 1800
- headspace — mental health support for 12 to 25 year olds: headspace.org.au
- Emergency: 000
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.
Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Contact this trial
Principal Investigator: Michael Rafii, MD, PhD, University of Southern California (USC) Keck School of Medicine, Alzheimer's Therapeutic Research Institute (ATRI)
Phone: 213-821-0569
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 4
Sponsor
Michael Rafii, MD, PhD
Registry
ClinicalTrials.gov
Start date
1 August 2026
Est. completion
31 December 2028
Primary endpoints
Change from baseline on brain amyloid levels
Can't join this trial?
Data last synced from ClinicalTrials.gov: 17 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.