Phase 2 Alzheimer's Disease Trial, Completed NCT04491006 Sponsor: LeonaBio Condition: Alzheimer's Disease
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Trial results

AI generated results 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

According to the results reported on ClinicalTrials.gov, this trial (NCT04491006) enrolled 77 people across three groups: 24 received a placebo (a dummy treatment with no active ingredient), 27 received a lower dose of a drug called ATH-1017 (40 mg), and 26 received a higher dose of ATH-1017 (70 mg). The trial was measuring brain activity using a test called P300 — a way of recording how the brain responds to sound cues, which can reflect how well working memory is functioning. It also measured thinking and memory abilities using a standard questionnaire called the ADAS-Cog11, where scores range from 0 (no impairment) to 70 (severe impairment). These measurements were taken at the start of the trial (Day 1, called "baseline") before any treatment effect could occur, so they represent a starting snapshot of each group. The reported data shows the following baseline brain activity readings (measured in milliseconds — the time it takes the brain to respond to a sound): the placebo group averaged 361.5 ms, the 40 mg ATH-1017 group averaged 382.3 ms, and the 70 mg ATH-1017 group averaged 375.3 ms. For the thinking and memory questionnaire at baseline, the reported data shows the placebo group scored an average of 23.0, the 40 mg group scored 22.4, and the 70 mg group scored 20.7. Because these are starting-point measurements taken before the trial treatments were properly underway, they describe where participants began rather than any change over time. No outcome data beyond these baseline figures was included in the structured results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 2 Alzheimer's Disease Trial, Completed

NCT04491006
Completed Phase 2 🇦🇺 Australian site

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

  • 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

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.

  • 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.

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 13 August 2026

If you need support right now

This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.

If you or someone else is in immediate danger, call 000.

  • Lifeline — 24/7 crisis support: 13 11 14
  • Suicide Call Back Service — 24/7 counselling: 1300 659 467
  • 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
  • Beyond Blue — 24/7 mental health support: 1300 22 4636
  • Emergency: 000

Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.

Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.

Trial contact details on record

Australian sites

Central Coast Neurosciences Research, Central Coast, New South Wales
St Vincent's Centre for Applied Medical Research, Translational Research Centre, Darlinghurst, New South Wales
Hammondcare Greenwich Hospital, Greenwich, New South Wales
KaRa MINDS, Macquarie Park, New South Wales
HammondCare, Malvern, Victoria
Australian Alzheimer's Research Organization, Nedlands, Western Australia

This trial is not accepting new participants. These are the contact details ClinicalTrials.gov holds for it, kept here for reference. They are not an invitation to enrol, and the sites listed may no longer be running this trial.

GP referral letter

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

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 was run

🇦🇺 Australia 🇺🇸 United States

These are the locations recorded on the registry, including 6 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

Event-related Potential (ERP) P300 Latency at Baseline

Other options

Expanded access pathways

This trial is not enrolling. Other access pathways exist in general: in Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients. Whether it applies to any treatment studied here is a question for your doctor — nothing on this page says it does.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 13 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