Phase 1 Alzheimer's Disease Trial, Not Yet Recruiting NCT07758595 Sponsor: Denali Therapeutics Inc. Condition: Alzheimer's Disease
Back to Alzheimers Disease

Phase 1 Alzheimer's Disease Trial, Not Yet Recruiting

NCT07758595
Not Yet Recruiting Phase 1

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

Healthy participants:

  • Adults aged 18 to 60 years old, male or female, who are not able to become pregnant
  • People with a body mass index (BMI) between 18 and 32, and a body weight of at least 50 kg
  • Female participants who are not able to become pregnant (for example, due to menopause or surgery)
  • Male participants who have had both testicles surgically removed, are completely abstinent, or agree to use two accepted forms of contraception during the trial

Participants with Alzheimer's disease (AD):

  • Adults aged 50 to 75 years old, male or female, who are not able to become pregnant
  • People with a BMI between 18 and 32, and a body weight of at least 45 kg
  • People who have been diagnosed with mild to moderate Alzheimer's disease, or early-stage memory and thinking problems believed to be caused by Alzheimer's disease, based on recognised medical guidelines
  • People with blood test results or a brain scan that show signs of Alzheimer's-related changes in the brain (specifically a positive plasma ptau217/Abeta42 blood test or a positive amyloid PET scan)
  • Female participants who are not able to become pregnant
  • Male participants who have had both testicles surgically removed, are completely abstinent, or agree to use two accepted forms of contraception during the 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.

Healthy participants:

  • People with a significant history of neurological, psychiatric, hormonal, lung, heart, digestive, liver, pancreas, kidney, metabolic, blood, immune, or allergy-related conditions, or other major health disorders
  • People who have a positive pregnancy test, or who are currently breastfeeding
  • People who have been in hospital in the 4 weeks before the screening visit

Participants with Alzheimer's disease:

  • People who have other significant brain or cognitive conditions besides Alzheimer's disease, as assessed by the study doctor
  • People with certain psychiatric conditions (confirm with trial site for specifics)
  • People with unstable or poorly managed conditions affecting hormones, lungs, heart, digestive system, liver, blood, or other significant health areas that the study doctor believes could affect the trial
  • People who have had cancer in the last 5 years, except for fully removed basal cell skin cancer or certain other cancers treated with the intent to cure and considered low risk of returning
  • People who have a positive pregnancy test, or who are currently breastfeeding
  • People who have been in hospital in the 4 weeks before the screening visit
  • People who have previously received anti-amyloid or anti-tau immunotherapy treatments, or who have taken part in experimental gene therapy or cell therapy at any point

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 12 August 2026

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Not Yet Recruiting
Phase
Phase 1
Sponsor
Denali Therapeutics Inc.
Registry
ClinicalTrials.gov
Start date
1 August 2026
Est. completion
1 April 2030

Primary endpoints

Part A: Incidence and severity of treatment-emergent averse events (TEAEs); Parts B and C: Incidence and severity of TEAEs in participants with AD

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: 12 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