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NCT03352557

NCT03352557
Terminated Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • 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:

  • 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.

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

Where this trial is recruiting

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

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

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

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