Phase 1 Alzheimer's Disease Trial, Recruiting NCT05591027 Sponsor: Oregon Health and Science University Condition: Alzheimer's Disease
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Phase 1 Alzheimer's Disease Trial, Recruiting

NCT05591027
Recruiting Phase 1

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

  • Adults aged between 60 and 85 years, male or female
  • People with sufficient English language skills to complete all required tests
  • People with sufficient vision and hearing to complete all required tests
  • People with no known allergies to Centella asiatica (a herbal plant)
  • People without significant signs of depression, based on a standard screening questionnaire score
  • People with a low score on questions related to suicidal thoughts on a standard depression screening questionnaire
  • People with a Body Mass Index (BMI) between 17 and 35 at the time of screening
  • People in a general state of health that would not prevent them from completing the study
  • People willing to stop taking all herbal or plant-based dietary supplements for one week before and throughout the study
  • People willing to undergo multiple MRI scans during the study
  • People who meet recognised medical criteria for mild cognitive impairment (MCI) or probable Alzheimer's disease (AD) dementia, with specific scores falling within set ranges on two standard memory and thinking assessments at screening and at the start of the study
  • People who report a gradual decline in memory over the past year must have that history confirmed by someone who knows them well, such as a family member or close friend
  • People already taking certain Alzheimer's medications (acetylcholinesterase inhibitors or memantine) must have been on a stable dose for at least 12 weeks before the study begins
  • People who have an identified caregiver or support person able to accompany them to all study visits

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 smoke, or who have issues with alcohol or substance use as defined by standard diagnostic criteria
  • Women who are pregnant, planning to become pregnant, or currently breastfeeding
  • Men who are actively trying to conceive a child, or planning to do so within three months of the study ending
  • People with a strong aversion to having blood drawn via a needle
  • People whose lab results show an untreated urinary tract infection without obvious symptoms
  • People who have had cancer within the last five years, except for certain low-grade localised prostate cancer or non-spreading skin cancers
  • People with certain serious health conditions, including type 1 diabetes, poorly controlled type 2 diabetes, kidney failure, liver failure, hepatitis, blood disorders, a condition causing low blood pressure when standing, or unstable or significantly symptomatic heart disease
  • People with serious brain or nervous system conditions such as a brain tumour, seizure disorder, bleeding around the brain, inflammation of brain arteries, or a clinically significant stroke
  • People with major depression, schizophrenia, or another major psychiatric condition as defined by standard diagnostic criteria
  • People currently taking certain medications, including anti-epileptics, sedatives, amitriptyline, blood thinners such as warfarin, experimental drugs taken within a specific timeframe before the study, corticosteroids, antipsychotics, Parkinson's medications, strong pain medicines, nicotine products, cannabis products, beta blockers, or antidepressants (including SSRIs and SNRIs) that have not been at a stable dose for at least two months
  • People whose dementia is caused by something other than Alzheimer's disease, such as vascular dementia, normal pressure hydrocephalus, or Parkinson's disease
  • People whose score on a standard memory and thinking test falls outside a specific range (below 20 or above 28)
  • People unwilling to keep their Alzheimer's medications at a stable dose throughout the study
  • People unwilling to take the study supplement at a consistent dose throughout the study
  • People who are unable to have MRI or related brain scans, for example due to certain metal implants, a pacemaker, or claustrophobia

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 10 August 2026

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: Amala Soumyanath, Ph.D, Oregon Health and Science University

Phone: 503-494-6878

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 1
Registry
ClinicalTrials.gov
Start date
1 December 2022
Est. completion
30 November 2025

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.

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change from baseline in brain N-acetylaspartate (NAA) to creatine (Cr) metabolite ratio (NAA/Cr) after 6 weeks on intervention.

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: 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.

View original record on ClinicalTrials.gov