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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT03757325

NCT03757325
Completed Phase 1

Who may be able to join

Who might be able to join this trial:

  • You are a man, or a woman who is not able to become pregnant, and you are between 55 and 85 years old
  • You have been diagnosed with Alzheimer's disease based on specific guidelines set out in 2011 by a major research organisation
  • You have supporting evidence of your Alzheimer's diagnosis from either a spinal fluid test or a brain scan that detected amyloid (a protein linked to Alzheimer's)
  • Your memory and thinking abilities fall within a specific range on a standard assessment test given at the screening visit (confirm with trial site)
  • Your overall level of impairment falls within a specific range on another standard assessment scale given at the screening visit (confirm with trial site)
  • You have someone in your life, such as a family member or carer, who knows you well, sees you regularly, can report on how you are doing, help you take the study treatment at home, and is willing to sign a consent form
  • Any approved Alzheimer's medications or other prescription drugs you take have been at a stable dose for at least one month before the screening visit and are expected to stay stable throughout the study

Who may not be able to join:

  • You have been diagnosed in the last two years, or currently show signs, of any other brain or nervous system condition (apart from Alzheimer's) that affects memory or thinking
  • A brain scan (MRI) taken at or within one year before the screening visit shows signs of any brain or nervous system condition other than Alzheimer's that affects memory or thinking

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.

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.

Trial details

Status
Completed
Phase
Phase 1
Sponsor
Denali Therapeutics Inc.
Registry
clinicaltrials_gov
Start date
13 February 2019
Est. completion
5 December 2019

Where this trial is recruiting

🇳🇱 Netherlands 🇺🇸 United States

Primary endpoints

Number of Subjects with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs); Number of Subjects with clinically significant neurological examination abnormalities; Number of Subjects with laboratory test abnormalities

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: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov