Phase 2 Alzheimer's Disease Trial, Recruiting NCT06775964 Sponsor: Paul E Schulz Condition: Alzheimer's Disease
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Phase 2 Alzheimer's Disease Trial, Recruiting

NCT06775964
Recruiting Phase 2

Who may 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 might be able to join this trial:

  • People who have signed a consent form before any study-related assessments begin
  • People aged between 60 and 80 years old (male or female)
  • People who have been diagnosed, or are in the process of being diagnosed, with late pre-symptomatic or mild memory and thinking difficulties linked to Alzheimer's disease
  • People who score 22 or higher on a standard memory and thinking test called the MMSE
  • People who have had, or are able to have, an MRI brain scan to assess Alzheimer's-related changes (a scan done within the last 6 months may be accepted)
  • People who have had, or are able to have, a genetic test to check for a gene called APOE, which is linked to Alzheimer's disease (a previous result may be accepted)
  • People who are proficient in English, as all thinking and memory tests are conducted in English only
  • People who have evidence of a specific protein build-up in the brain (amyloid), shown through either a PET scan or a spinal fluid test
  • People who have blood test results showing signs of inflammation in the body, based on specific markers being above certain levels (confirm with trial site for exact values)
  • People who are considered to be in generally good health based on medical history, physical check-up, blood tests, vital signs, and a heart trace (EKG), in the opinion of the treating doctor

Who may not be able to join:

  • People who have another medical or neurological condition that could affect memory or thinking, such as a brain injury, Parkinson's disease, or multiple sclerosis
  • People who are unable or unwilling to complete memory and thinking tests
  • People who have a serious, advanced, or unstable illness that could affect safety or interfere with the study, such as significant heart disease, severe kidney or liver problems, or an autoimmune condition
  • People who have had a cancer diagnosis in any part of the body within the past 5 years, if the investigator believes this could affect how safety or results are assessed
  • People who are pregnant (applies to women who could become pregnant)
  • People who are unable or unwilling to have a PET scan
  • People who are unable or unwilling to have an MRI scan
  • People who test positive for HIV, Hepatitis B, Hepatitis C, or Syphilis in a blood test
  • People who test positive for a specific genetic variation called TSPO SNP rs6971 (confirm with trial site)
  • People who are unable or unwilling to undergo a lumbar puncture (a procedure to collect fluid from around the spine)
  • People who are unable or unwilling to receive infusions (medication delivered directly into a vein)
  • People who have any other condition that, in the investigator's opinion, could put them at risk or affect how the study results are interpreted

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 28 July 2026
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.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Paul E Schulz, MD, The University of Texas Health Science Center, Houston

Phone: 713-486-0531

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 2
Sponsor
Paul E Schulz
Registry
ClinicalTrials.gov
Start date
11 March 2026
Est. completion
1 January 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in TSPO levels, measured by the PET scan, from baseline to midpoint and baseline to end of study; Inflammatory cytokines in CSF following adMSC therapy

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: 28 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