Phase 1 Alzheimer's Disease Trial, Recruiting NCT07328451 Sponsor: Denali Therapeutics Inc. Condition: Alzheimer's Disease
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Phase 1 Alzheimer's Disease Trial, Recruiting

NCT07328451
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:

  • Your Body Mass Index (BMI) is between 18 and 32, and you weigh at least 45 kg (about 99 lbs)
  • You have been diagnosed with Alzheimer's disease (AD) dementia based on recognized medical criteria, which may include memory-related or other thinking-related symptoms
  • There is supporting evidence from past medical records or recent tests showing the presence of amyloid (a protein linked to Alzheimer's disease) in your body
  • Your Alzheimer's disease is considered mild, shown by specific scores on two standard memory and thinking tests (a Clinical Dementia Rating score of 0.5 or 1, and a Mini-Mental State Examination score between 20 and 30)

Who may not be able to join:

  • You have a significant brain or thinking disorder other than Alzheimer's disease, as judged by the study doctor
  • You have a significant psychiatric (mental health) condition
  • You have any unstable or poorly managed condition affecting organs such as your lungs, heart, digestive system, liver, or blood, which the study doctor believes could affect the study
  • You have been diagnosed with cancer in the last 5 years (some exceptions may apply, such as certain low-risk or fully treated skin cancers — confirm with trial site)
  • You have previously received any treatment designed to target amyloid or tau proteins in the brain, including certain types of immunotherapy vaccines (some exceptions may apply for certain participants — confirm with trial site)
  • You have previously received gene therapy of any kind

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 21 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

Principal Investigator: Medical Monitor, Denali Therapeutics

Phone: Email:

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
Denali Therapeutics Inc.
Registry
ClinicalTrials.gov
Start date
30 January 2026
Est. completion
1 February 2027

Where this trial is recruiting

🇳🇱 Netherlands 🇬🇧 United Kingdom

Primary endpoints

Incidence and severity of treatment-emergent adverse events (TEAEs) throughout the double-blind period

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: 21 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