Phase 2 Alzheimer's Disease Trial, Not Yet Recruiting NCT07205601 Sponsor: Regeneration Biomedical, Inc. Condition: Alzheimer's Disease
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Phase 2 Alzheimer's Disease Trial, Not Yet Recruiting

NCT07205601
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

  • People aged 45 to 85 years old
  • People who have been diagnosed with mild to moderate Alzheimer's disease
  • People whose Alzheimer's disease has been assessed as stage 4 or 5 on the Functional Assessment Staging Test (FAST) — a scale used to measure how the disease is progressing (confirm with trial site)
  • People who score between 10 and 23 on the Mini-Mental State Examination (MMSE), a standard memory and thinking test
  • People whose brain scan (amyloid PET scan) shows a centiloid score above 30, indicating a certain level of a protein linked to Alzheimer's disease (confirm with trial site)
  • People whose spinal fluid test results (called ADmark® CSF analysis) show specific levels of two markers linked to Alzheimer's disease (confirm with trial site)
  • People who do not have any tumours or other conditions that could explain their dementia symptoms
  • People who are otherwise in good general health
  • People who have provided written agreement to take part, either themselves or through a legal representative
  • People who have a caregiver who separately meets the trial's own caregiver eligibility requirements
  • People who are able to donate a sufficient amount of body fat tissue (called lipoaspirate) to produce the treatment used in this trial

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 are taking certain medications that are not allowed in this trial
  • People who have previously received a cell-based therapy
  • People who have an existing ventriculoperitoneal shunt (a device surgically implanted to drain fluid from the brain)
  • People who have a neurological condition other than Alzheimer's disease
  • People who have a psychiatric condition such as schizophrenia, bipolar disorder, unipolar depression, or delirium
  • People who have had problems with drug or alcohol use in the past 2 years
  • People who have had a cancer diagnosis within the past 5 years
  • People who do not have a caregiver available who meets the trial's caregiver eligibility requirements
  • People who have taken part in another clinical trial involving a monoclonal antibody in the past 3 months, or any other investigational treatment in the past 6 months

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 August 2026

Contact this trial

Phone: 877-240-1660

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
Sponsor
Regeneration Biomedical, Inc.
Registry
ClinicalTrials.gov
Start date
1 November 2025
Est. completion
1 March 2028

Primary endpoints

Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Composite Score

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 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