Phase 2 Alzheimer's Disease Trial, Terminated NCT03352557 Sponsor: Biogen 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 (NCT03352557) tested a drug called BIIB092 (also known as gosuranemab) in people with Alzheimer's disease. The trial had two main phases: a placebo-controlled (PC) period lasting up to 78 weeks, where 654 people were assigned to receive either a dummy treatment (placebo) or one of four different doses of BIIB092; and a longer-term extension (LTE) period from around week 80 to week 173, where 521 participants continued on active doses of BIIB092. The primary thing the trial was measuring was how often participants experienced adverse events (AEs) — that is, any unwanted medical occurrence during the study — and serious adverse events (SAEs), which are more severe medical events such as hospitalisation or life-threatening situations. The reported data shows that during the placebo-controlled period, adverse events were recorded in roughly 83–89% of participants across all groups, including the placebo group (84.6%). Serious adverse events were reported in approximately 10–12% of participants across all groups, including 12.1% in the placebo group. During the longer-term extension period, adverse events were reported in roughly 55–69% of participants depending on the dose group, and serious adverse events were reported in approximately 2–11% of participants across those groups. The reported data also shows that very few participants developed detectable antibodies against BIIB092 in their blood — ranging from 0% in most dose groups to 1.9% in the placebo group. For one of the secondary measures — a standard cognitive assessment called the CDR-SB, which scores memory and thinking ability on a scale from 0 to 18 — the reported data shows that average scores increased (meaning more impairment) across all groups over 78 weeks, ranging from about 2.92 to 3.24 points in the BIIB092 groups and 3.07 points in the placebo group, though the spread of individual results within each group was also noted. 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, Terminated

NCT03352557
Terminated 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 have experienced a slow, gradually worsening change in memory that has been happening for more than 6 months.
  • You have been diagnosed with mild cognitive impairment (MCI) or mild Alzheimer's disease, based on standard medical assessments.
  • Your memory and thinking problems have been confirmed through specific tests at a screening visit (confirm with trial site for exact test details).
  • Your score on a standard memory and thinking test (called the MMSE) falls between 22 and 30 out of 30.
  • Your scores on a standard disease rating scale (called the CDR) meet specific levels showing mild impairment (confirm with trial site for exact score requirements).
  • You are willing to have a genetic test related to Alzheimer's risk (called ApoE genotyping).
  • You have a family member, friend, or carer who knows you well and can take part in the study alongside you as a "study partner."
  • A brain scan or other test has confirmed the presence of a protein linked to Alzheimer's disease (called amyloid beta) in your body.

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 another medical or brain-related condition (other than Alzheimer's) that could be causing your memory problems or that could affect your safety or ability to take part.
  • You have a significant and unstable mental health condition, such as severe psychiatric illness.
  • You have had a stroke, a mini-stroke (TIA), or an unexplained loss of consciousness in the past year.
  • You have a history of significant bleeding in the brain, a blood clotting disorder, or abnormal blood vessels in the brain.
  • You have had unstable chest pain (angina), a heart attack, serious heart failure, or significant heart rhythm problems within the past year.
  • You have signs of poor kidney or liver function.
  • You have had a problem with alcohol or drug misuse in the past year.
  • You have had a significant illness or serious infection within the 30 days before or during the screening period.
  • You are taking medications for ongoing conditions whose doses have not been stable for at least 4 weeks before screening, or Alzheimer's medications that have not been at a stable dose for at least 8 weeks before screening.
  • You are taking any medication that, in the doctor's opinion, could affect your memory and thinking, increase your risk of side effects, or interfere with study tests and procedures.
  • You have any other reason that would make the study procedures unsafe or unsuitable for you (confirm with trial site).

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

Trial contact details on record

Principal Investigator: Medical Director, Biogen

Australian sites

Box Hill Hospital, Box Hill, Victoria
Caulfield Hospital, Caulfield, Victoria
Austin Hospital, Heidelberg West, Victoria
Royal Melbourne Hospital, Melbourne, Victoria
The Alfred Hospital, Melbourne, Victoria

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
Terminated
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
3 May 2018
Est. completion
30 August 2021

Where this trial was run

🇦🇺 Australia 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇯🇵 Japan 🇵🇱 Poland 🇪🇸 Spain 🇸🇪 Sweden 🇺🇸 United States

These are the locations recorded on the registry, including 5 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

PC Period: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs); LTE Period: Percentage of Participants With AEs and SAEs

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