Phase 1 Alzheimer's Disease Trial, Recruiting NCT07218081 Sponsor: Augusta University Condition: Alzheimer's Disease
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Phase 1 Alzheimer's Disease Trial, Recruiting

NCT07218081
Recruiting Phase 1

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:

  • You must be between 65 and 85 years old
  • You must have been diagnosed with early-stage Alzheimer's Disease, confirmed by a specific brain scan that detects a protein called beta amyloid
  • Your Alzheimer's must be at an early, mild stage, based on standard memory and thinking tests (scores within a specific range on tests called CDR and MMSE)
  • You must not have any other type of dementia (such as Lewy Body dementia)
  • If you take any medication for memory or mood, the dose must have been stable for at least 60 days, and must be a low dose (confirm with trial site)
  • You must be able to give your own informed consent to participate
  • You must have a caregiver who is available and willing to take part in the study with you
  • You must be living at home and expected to remain at home for the whole length of the study
  • You must have a low score on a depression screening test (Geriatric Depression Scale of 5 or less)
  • You must not have significant thoughts of suicide, based on a standard screening questionnaire
  • You must not be experiencing strong delusions, hallucinations, or agitation/aggression, based on a behaviour questionnaire

Who may not be able to join:

  • You may not be eligible if you have had a serious head injury, brain tumour, bleeding around the brain, or other significant brain problems in the last 2 years
  • You may not be eligible if you have a medical implant that would prevent you from having a high-powered MRI scan (confirm with trial site)
  • You may not be eligible if you currently have or have a history of a major psychiatric condition such as schizophrenia, bipolar disorder, or severe depression
  • You may not be eligible if you have a history of suicide attempts or suicidal crises
  • You may not be eligible if you have another brain or nervous system condition, such as Parkinson's disease, stroke, or other forms of dementia
  • You may not be eligible if you have a history of seizures or epilepsy
  • You may not be eligible if you have a serious illness where life expectancy is less than 30 months
  • You may not be eligible if you have another recognised form of dementia, such as those caused by Lewy body disease, Huntington's disease, HIV, Parkinson's disease, vascular disease, traumatic brain injury, or prion disease
  • You may not be eligible if you have any unstable medical or neurological conditions, as judged by the lead doctor running the trial

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 7 July 2026
Phase 1: approximately ~10% 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

Phone: 415-515-2659

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
Sponsor
Augusta University
Registry
ClinicalTrials.gov
Start date
1 February 2026
Est. completion
1 November 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Dementia Rating Scales; Alzheimer's Disease Assessment Scale, Cognitive Subscale

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: 7 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