Phase 2 Alzheimer's Disease Trial, Recruiting NCT07688213 Sponsor: Sanofi Condition: Alzheimer's Disease
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Phase 2 Alzheimer's Disease Trial, Recruiting

NCT07688213
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 between 55 and 85 years (inclusive) at the time of signing the consent form.
  • People who have been diagnosed with either mild cognitive impairment due to Alzheimer's disease, or mild Alzheimer's disease dementia (specific stages as defined by NIA-AA guidelines).
  • People who have scored between 0.5 and 1.0 on a standard memory and thinking assessment called the Clinical Dementia Rating scale, with a memory-specific score of at least 0.5 at the screening visit.
  • People who have a study partner who is over 18 years old, has known the participant for at least one year, spends at least 8 hours per week with the participant, and is willing to provide written consent to take part separately.
  • People who have a brain scan (called an amyloid PET scan) showing the presence of amyloid plaques, which are a key feature of Alzheimer's disease.

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 a history of significant brain or neurological conditions, including (but not limited to) frontotemporal dementia, Lewy body dementia, Huntington's disease, serious brain infection, Parkinson's disease, multiple concussions, multiple sclerosis, or epilepsy or repeated seizures (childhood febrile seizures are an exception).
  • People whose brain scans show more than 4 very small bleeds (under 10mm) or a condition called superficial siderosis (iron deposits on the brain surface).
  • People who carry two copies of a specific gene variant called APOE4 (sometimes written as APOE4/4).
  • People who are currently receiving, or have previously received, any anti-amyloid immunotherapy treatment (such as aducanumab, lecanemab, or donanemab) or a type of therapy that targets a protein called TREM-2.
  • People who are currently taking blood-thinning (anticoagulant) medications.
  • People who have had a cancer diagnosis in the 3 years before the screening visit, with some exceptions including certain skin cancers, early-stage prostate cancer, fully removed kidney cancers, and successfully treated cervical carcinoma in situ (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 6 August 2026

Contact this trial

Phone: 800-633-1610

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
Registry
ClinicalTrials.gov
Start date
1 July 2026
Est. completion
31 July 2029

Primary endpoints

Part A and optional dose 2 cohort: change from baseline to Week 48 in plasma p-tau217; Part B: Number of participants with treatment-emergent adverse events (TEAE), including ARIA-E and ARIA-H by brain MRI, laboratory assessments, vital sign measurements, ECGs and the C-SSRS

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: 6 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