Alzheimer's Disease Trial, By Invitation NCT05882344 Sponsor: Vanderbilt University Medical Center Condition: Alzheimer's Disease
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Alzheimer's Disease Trial, By Invitation

NCT05882344
By Invitation Not Applicable

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 have been diagnosed with probable, early-stage Alzheimer's disease, including a condition called Mild Cognitive Impairment (MCI) affecting memory, based on specific 2018 diagnostic guidelines.
  • People who score between 0.5 and 1.0 on a standard memory and thinking assessment called the Clinical Dementia Rating (CDR), with a memory-specific score of at least 0.5.
  • People who score 23 or higher on a standard thinking and memory test called the Mini-Mental State Examination (MMSE).
  • People who have been on a stable dose of memory-support medication (equivalent to 10 mg per day of donepezil or less) for at least 60 days before joining.
  • People whose other medications, such as those for mood or mental health, have been at a stable dose for a period of time.
  • Women who are either past menopause, have had a surgical procedure that means they cannot become pregnant, or are willing to use birth control for the entire duration of the study.
  • People who have a carer or family member available who is willing to take part in the study alongside them.
  • People who are currently living at home and expect to continue living at home for the full duration of the study.

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 with an active or unstable mental health condition.
  • People who are unable to tolerate general anaesthesia.
  • People who have another brain or nervous system condition that could interfere with the study, such as a history of stroke, Parkinson's disease, Lewy Body dementia, another form of dementia, or other significant brain structural problems.
  • People who have a current major mental health disorder such as schizophrenia, bipolar disorder, or major depressive disorder, as identified during a psychiatric assessment at the screening visit.
  • People whose verbal IQ score is below 85.
  • People who have a medical reason that prevents them from safely having anaesthesia, stereotactic brain procedures, MRI scans (for example, claustrophobia or certain implanted devices), or PET scans (for example, insulin-dependent diabetes).
  • People who are unable to undergo PET or MRI imaging for any reason.
  • People with a current alcohol or substance use disorder, as defined by standard diagnostic criteria.
  • People who are unable or unwilling to attend required follow-up visits as set out in the study protocol.
  • People who are currently enrolled in another clinical trial.
  • People with a terminal illness where survival of less than 12 months is expected.

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.
Last synced 18 August 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

If this is close to home

This page includes language about advanced illness, prognosis, or palliative care, because that is how the trial's eligibility criteria are written. Seeing it set out plainly can land hard, whether it is about you or about someone you are caring for. You do not have to be at a crisis point to talk to someone.

  • Griefline — grief and loss counselling, 9am to 6pm weekdays and midday to 6pm weekends (AEST/AEDT): 1300 845 745
  • Carer Gateway — practical and emotional support if you are caring for someone, 8am to 5pm weekdays: 1800 422 737
  • Canteen — for 12 to 25 year olds affected by cancer, their own or a family member's: 1800 945 215
  • Palliative Care Australia — directory of palliative care services near you: palliativecare.org.au
  • Lifeline — 24/7, for any kind of distress, at any hour the services above are closed: 13 11 14

Palliative care is not the same as giving up on treatment, and it is not only for the last weeks of life. It is symptom and comfort care that can run alongside active treatment, including a clinical trial.

Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of support and crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention.

Voxsanity is not a counselling or medical service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.

GP referral letter

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Trial details

Status
By Invitation
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
1 July 2026
Est. completion
1 October 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Clinical Dementia Rating score change

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

View original record on ClinicalTrials.gov