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

NCT04491006

NCT04491006
Completed Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You are between 55 and 85 years old
  • You have been diagnosed with mild-to-moderate Alzheimer's disease dementia, based on recognised medical guidelines
  • Your memory and thinking scores fall within a specific range, as measured by standard tests given at the screening visit
  • You have a reliable family member, friend, or caregiver who can support you throughout the trial
  • You are either not currently taking any Alzheimer's medication, OR you have been on a stable approved dose of a specific type of Alzheimer's medication (called a cholinesterase inhibitor) for at least 3 months before screening, OR you stopped taking that type of medication at least 4 weeks before screening

Who may not be able to join:

  • You have a history of another significant brain or neurological condition (other than Alzheimer's) that affects thinking or memory
  • You have a history of unexplained blackouts or seizures (unless they were caused by a high fever)
  • You have an unusual or atypical form of Alzheimer's disease, if this is known from your medical history
  • A previous brain MRI scan showed significant abnormalities unrelated to Alzheimer's
  • Your hearing is not at a level suitable for a specific type of brain response test used in this trial (confirm with trial site)
  • You have been diagnosed with severe clinical depression, even without additional symptoms such as hallucinations
  • You are considered to be at significant risk of suicide
  • You have been diagnosed with, or treated for, psychosis in the last 2 years
  • You had a heart attack or unstable chest pain within the last 6 months
  • You have a significant heart rhythm problem, heart muscle disease, or electrical conduction problem in your heart (note: having a pacemaker is acceptable)
  • You have high blood pressure above a certain level, or low blood pressure that causes symptoms
  • You had a significant abnormal heart trace (ECG) result at your screening visit
  • Your kidneys are not functioning well enough, based on a specific blood test result
  • Your liver is not functioning well enough, based on specific blood test results or a recognised liver disease scoring system
  • You have had a cancerous tumour within the 3 years before screening
  • You have taken a medication called memantine (in any form or dose) within 4 weeks before screening
  • You have taken a specific high dose (23 mg) of a medication called donepezil
  • You have ever received a vaccine for Alzheimer's disease, or have received certain Alzheimer's antibody treatments within 6 months of screening

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 2: approximately ~30% 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 2
Sponsor
LeonaBio
Registry
clinicaltrials_gov
Start date
23 November 2020
Est. completion
20 May 2022

Where this trial is recruiting

🇦🇺 Australia 🇺🇸 United States

6 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Event-related Potential (ERP) P300 Latency at Baseline

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