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NCT06544616

NCT06544616
Active, Not Recruiting Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • A brain scan (called a tau PET scan) has shown an elevated level of a protein called tau, which is associated with Alzheimer's disease, above a certain threshold
  • You currently have no signs of memory or thinking problems, as measured by a standard assessment called the CDR (your score must be 0)
  • You scored 27 or higher on a standard memory and thinking test called the MMSE (with some adjustment based on your level of education)
  • You are able to read and write and have had at least 5 years of formal schooling
  • You are not able to become pregnant (confirm with trial site for specific requirements)

Who may not be able to join:

  • You have a known or suspected inherited (genetic) form of Alzheimer's disease that runs in the family
  • You have already been diagnosed with Alzheimer's dementia or another type of dementia (such as Lewy body dementia, frontotemporal dementia, vascular dementia, or Parkinson's dementia, among others)
  • You have already been diagnosed with Mild Cognitive Impairment (MCI), which is a recognised early stage of memory or thinking decline
  • Your blood tests show low levels of Vitamin B12 or folate, unless the study doctor decides this does not need to be treated during the trial
  • You have a neurological (brain or nervous system) condition other than early/preclinical Alzheimer's disease that could make it hard to interpret any new symptoms that appear during 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.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Active, Not Recruiting
Phase
Phase 2
Sponsor
Janssen Pharmaceutica N.V., Belgium
Registry
clinicaltrials_gov
Start date
22 July 2024
Est. completion
22 December 2026

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇫🇷 France 🇩🇪 Germany 🇯🇵 Japan 🇪🇸 Spain 🇸🇪 Sweden 🇬🇧 United Kingdom 🇺🇸 United States

7 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Change From Baseline in Brain Tau Burden as Measured by Tau PET in Specified Regions of Interest (ROI)

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: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov