Alzheimer's Disease Trial, By Invitation NCT05457998 Sponsor: Butler Hospital Condition: Alzheimer's Disease
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Alzheimer's Disease Trial, By Invitation

NCT05457998
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 aged between 50 and 80 years old (inclusive).
  • People who score 16 or above on a telephone-based memory and thinking test called the MoCA.
  • People aged 50 to 64 who score 27 or above on a standard cognitive test called the MMSE, or people aged 65 to 80 who score 26 or above on the same test.
  • People aged 50 to 60 must also meet at least one of the following: (1) a close blood relative (parent, sibling, or child) was diagnosed with dementia before age 75; (2) they carry a gene variant called APOE e4; or (3) a previous brain scan or spinal fluid test showed elevated levels of a protein called amyloid.
  • People who are conversationally fluent in English to a level where an interpreter is not needed to understand study information, procedures, and cognitive tests.
  • If a person chooses to take part in an optional results-disclosure process within the study, they must have a suitable study partner who agrees to participate, is able to understand and communicate in English without an interpreter, and has no significant intellectual, vision, or hearing difficulties.
  • People with sufficient vision and hearing to complete neuropsychological (brain and thinking) tests.
  • People who are willing and able to sign a written consent form agreeing to take part.

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 already been diagnosed with mild cognitive impairment or dementia.
  • People with a history of significant brain injury or a neurological (brain or nervous system) condition that has caused lasting effects on thinking or memory — for example, Huntington's disease, Parkinson's disease, epilepsy, stroke with lasting cognitive effects, or a past brain infection (confirm with trial site for full list).
  • People with a serious or unstable physical illness or organ failure that, in the lead researcher's judgement, would make participation difficult — such as terminal cancer or serious heart, liver, kidney, lung, or other major organ disease; however, a history of cancer is acceptable if the person has been in remission for at least one year with a good outlook.
  • People who have had clinically significant depression, bipolar disorder, anxiety, or thoughts of suicide within the past year, as defined by the current psychiatric diagnostic guidelines (DSM).
  • People with a history of schizophrenia as defined by the current psychiatric diagnostic guidelines (DSM).
  • People with a history of chronic alcohol or drug misuse or dependence within the past year, as defined by the current psychiatric diagnostic guidelines (DSM).
  • People who use marijuana frequently will be asked to stop using it at least 24 hours before any study assessments (occasional use is otherwise acceptable).
  • People who are unwilling or unable to complete the study procedures.
  • People who are currently enrolled in another study involving a clinical drug trial or other medical intervention.

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 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.

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

Print a one-page summary to share with your doctor.

Trial details

Status
By Invitation
Phase
Not Applicable
Sponsor
Butler Hospital
Registry
ClinicalTrials.gov
Start date
14 June 2023
Est. completion
1 June 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Rate of change in plasma biomarkers; Rate of change in cerebral amyloid pathology; Rate of change in Tau PET measures

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