Phase 2 Alzheimer's Disease Trial, Not Yet Recruiting NCT07756294 Sponsor: Wake Forest University Health Sciences Condition: Alzheimer's Disease
Back to Alzheimers Disease

Phase 2 Alzheimer's Disease Trial, Not Yet Recruiting

NCT07756294
Not Yet Recruiting Phase 2

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

  • The person must be fluent in English.
  • The person must have a previously documented clinical diagnosis of mild cognitive impairment due to Alzheimer's disease, or mild Alzheimer's disease.
  • The person must have tested positive for amyloid (a protein linked to Alzheimer's disease) through a brain scan (PET) or spinal fluid test.
  • The person's general health must have been stable for at least 3 months before the screening visit.
  • The person's medications for general health conditions must have remained unchanged for at least 4 weeks before the screening and study visits (the study clinician may make exceptions on a case-by-case basis).
  • The person must have been on an anti-amyloid treatment (lecanemab or donanemab) without changes for at least 8 weeks before the baseline visit.
  • If the person is taking certain memory-related medications (donepezil, rivastigmine, galantamine, or memantine), the dose must have been unchanged for at least 30 days before the baseline visit.
  • The person's routine blood and lab test results must be within normal ranges, or any abnormal results must be considered medically unimportant by the study clinician.
  • The person must have a study partner who agrees to take part throughout the whole study, spends around 10 hours per week with them, and can reliably report on the person's thinking and daily functioning.

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 been diagnosed with a type of dementia other than Alzheimer's disease.
  • People who have had a clinically significant stroke, a mini-stroke (transient ischemic attack) within the past 12 months, or any history of seizures.
  • People who, in the past two years, have had a head injury with loss of consciousness, or who have a history of a major psychiatric condition such as psychosis, unstable severe depression, or bipolar disorder.
  • People who have type 1 or type 2 diabetes, whether or not they use insulin.
  • People who are currently using or have used insulin or any other diabetes medication within 2 months of the screening visit.
  • People who have had cancer within the past 2 years, with exceptions for certain skin cancers and stable, non-spreading prostate cancer of at least 6 months.
  • People who are pregnant or may be pregnant.
  • People who use blood-thinning medications (anticoagulants).
  • People who are living in a skilled nursing facility at the time of screening.
  • People who have used an experimental medication or treatment within 2 months of the screening visit.
  • People who regularly use alcohol, narcotics, anti-seizure medications, Parkinson's medications, or other medications that may disqualify them (the study clinician may make exceptions on a case-by-case basis).
  • People who have a history of an immune system disease (such as lupus, rheumatoid arthritis, or Crohn's disease), or who have been treated with medications that suppress the immune system.
  • People who have a bleeding disorder that is not well controlled, including certain abnormal blood clotting results (confirm with trial site).
  • People who are unable to have an MRI scan, including those with claustrophobia or certain metal implants or a pacemaker.
  • People whose baseline MRI scan shows certain brain abnormalities, including too many small bleeds, a large bleed, signs of a specific type of brain swelling or inflammation, certain types of stroke damage, or other significant brain conditions that could affect thinking (confirm with trial site for full details).

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 14 August 2026

Contact this trial

Principal Investigator: Suzanne Craft, PhD, Wake Forest Alzheimer's Disease Research Center

Phone: 336-716-6463

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 2
Registry
ClinicalTrials.gov
Start date
1 August 2026
Est. completion
1 April 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of treatment-related serious adverse events

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: 14 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