Phase 3 Alzheimer's Disease Trial, Recruiting NCT07169578 Sponsor: Hoffmann-La Roche Condition: Alzheimer's Disease
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Phase 3 Alzheimer's Disease Trial, Recruiting

NCT07169578
Recruiting Phase 3

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 are willing and able to complete all parts of the study — including MRI scans, genetic testing, and PET or spinal fluid tests — for the full duration, either on their own or with help from a study partner
  • People whose vision and hearing are good enough, in the investigator's judgment, to complete memory and thinking tests (glasses and hearing aids are allowed)
  • People who have evidence of Alzheimer's disease confirmed by an amyloid PET scan, or by a spinal fluid test measuring certain protein levels if a PET scan is not available
  • People who have been diagnosed with probable Alzheimer's dementia or mild cognitive impairment due to Alzheimer's disease (also called Alzheimer's clinical Stage 3 or Stage 4)
  • People whose scores on two standard memory and thinking assessments fall within a specific range at screening (MMSE score of 22 or above, and a CDR-GS score of 0.5 or 1.0)
  • People who have a reported history of gradual memory or thinking decline that started and progressed over at least the 1 year before screening
  • People whose score on a specific memory test (the RBANS Delayed Memory Index) is 85 or below (confirm with trial site)
  • People who have a "study partner" available, as defined by the trial protocol

Who may not be able to join:

  • People who have any condition other than Alzheimer's disease that could affect memory or thinking
  • People who have a history of, or currently have, significant disease affecting blood flow in the brain (such as strokes)
  • People who have had a severe brain injury that caused lasting neurological damage or structural brain changes
  • People who have a history of, or currently have, a significant growth or mass inside the skull
  • People whose MRI scan shows significant abnormalities in the brain, or who are unable to tolerate or safely undergo an MRI
  • People who have other serious medical conditions — such as heart, liver, or kidney disease — that are not stable or well-controlled, or that the investigator believes could affect the person's safety or interfere with study results
  • People who have a history of cancer, unless the cancer is considered cured or carries a very low risk of spreading or causing serious harm

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 27 July 2026
Phase 3: approximately ~65% 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: Clinical Trials, Hoffmann-La Roche

Phone: 888-662-6728

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 3
Registry
ClinicalTrials.gov
Start date
17 September 2025
Est. completion
7 June 2028

Where this trial is recruiting

🇦🇷 Argentina 🇧🇷 Brazil 🇨🇦 Canada 🇨🇳 China 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇯🇵 Japan 🇵🇱 Poland 🇪🇸 Spain 🇹🇼 Taiwan 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Change from baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)

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: 27 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