Phase 1 Alzheimer's Disease Trial, Not Yet Recruiting NCT06600880 Sponsor: Columbia University Condition: Alzheimer's Disease
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Phase 1 Alzheimer's Disease Trial, Not Yet Recruiting

NCT06600880
Not Yet 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

  • People who are over 50 years of age.
  • People who have been diagnosed with Mild Cognitive Impairment (MCI) or Alzheimer's Disease (AD).
  • People whose score on a standard memory and thinking test (called the MMSE) falls between 12 and 26.
  • People whose score on a scale used to assess stroke-related thinking problems (the Modified Hachinski Ischemia Scale) is 4 or below.
  • People whose score on a short depression screening test (the Geriatric Depression Scale) is 6 or below.
  • People who have had a PET scan confirming the presence of amyloid plaques in the brain (using a tracer called Amyvid/18F-Florbetapir).
  • People who have had a PET scan confirming the presence of tau protein in the frontal lobe of the brain (using a tracer called MK-6240/F18-Florquinitau).
  • People who are able to give their own informed consent to take part in 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 who have previously been treated with any medication designed to reduce amyloid in the brain, such as aducanumab or lecanemab.
  • People for whom an MRI scan would not be safe or suitable.
  • People with a history of allergic reactions or sensitivities to MRI contrast dyes (such as Dotarem), ultrasound contrast agents (such as Definity or Lumason), or a related substance called polyethylene glycol (PEG).
  • People who have previously had brain surgery, including deep brain stimulation.
  • People who have metal implants in their body.
  • People with abnormal blood clotting results based on standard blood tests (confirm with trial site).
  • People who are currently taking blood-thinning medication.
  • People with a history of seizures or epilepsy.
  • People whose brain has shrunk to a degree that would interfere with the ultrasound treatment used in the study (confirm with trial site).
  • People who would be unable to follow all the steps of the study, including attending follow-up scans.
  • Women who are able to become pregnant, or who are currently breastfeeding.
  • People with significantly reduced kidney function, specifically an eGFR below 30 mL/min/1.73m², based on a blood test taken 2 to 4 weeks before treatment.
  • People with an active infection or inflammation.
  • People with certain types of bleeding in the brain, including more than 4 small bleeds in the outer brain regions, a condition called siderosis, or larger bleeds.
  • People with brain tumours or other significant growths taking up space in the brain.
  • People with any uncontrolled medical condition that could make it unsafe to take part in the study.

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 31 July 2026

Contact this trial

Principal Investigator: Grace McIlvain, PhD, Columbia University

Phone: 9295455655

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 1
Registry
ClinicalTrials.gov
Start date
1 August 2027
Est. completion
1 July 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Total Number of Individuals With Successful Opening of the BBB

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: 31 July 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