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NCT02670083

NCT02670083
Terminated Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You weigh between 40 and 120 kilograms (about 88 to 265 pounds)
  • You have someone in your life (like a family member or close friend) who sees you regularly, can accurately describe your memory and daily functioning, is willing to attend clinic visits and sign a consent form, and has good enough memory themselves to report on your condition
  • You are fluent in the language used for the tests at the study site
  • You have good enough vision and hearing to complete memory and thinking tests (glasses and hearing aids are allowed)
  • Testing of your spinal fluid or a brain scan shows signs of Alzheimer's-related changes (specifically, a protein called amyloid)
  • Memory tests done at or shortly before your screening visit show abnormal memory function (based on specific test scores — confirm with trial site)
  • Your score on a standard memory and thinking test (called the MMSE) is 22 or higher, and a doctor's rating of your daily functioning falls within a specific range (called CDR-GS 0.5 or 1.0)
  • A doctor has diagnosed you with probable Alzheimer's disease or early-stage memory impairment consistent with Alzheimer's, following recognised medical guidelines
  • If you are already taking medication for Alzheimer's symptoms, your dose has stayed the same for at least 3 months before the screening visit
  • You have completed at least 6 years of formal schooling after the age of 5

Who may not be able to join:

  • You have a condition other than Alzheimer's that affects memory or thinking, such as another type of dementia, stroke, brain injury, certain autoimmune diseases (like multiple sclerosis), or a past infection that affected the brain
  • You have a history of serious mental illness, such as schizophrenia, or depression that is not currently under control
  • The study doctor has concerns that you may be at risk of harming yourself
  • Your MRI brain scan shows certain abnormalities (such as signs of blood vessel problems or a past stroke), you are unable to tolerate an MRI scan, or you have a medical reason you cannot have an MRI
  • You have an unstable or serious heart, kidney, or liver condition (for example, a recent heart attack)
  • Your blood pressure is not well controlled
  • A blood test at screening shows your blood sugar control is poor (HbA1c above 8%)
  • Your veins make it difficult to take blood samples
  • You have a history of cancer, unless it is considered fully treated/cured or you are not currently receiving cancer treatment or radiotherapy
  • You have had a serious allergic reaction (including anaphylaxis) to certain types of antibody-based medicines in the past (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 3: approximately ~65% 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 3
Sponsor
Hoffmann-La Roche
Registry
clinicaltrials_gov
Start date
22 March 2016
Est. completion
31 May 2019

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇦 Canada Costa Rica 🇭🇷 Croatia 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany Hong Kong 🇭🇺 Hungary 🇮🇹 Italy 🇯🇵 Japan 🇱🇹 Lithuania 🇲🇽 Mexico 🇵🇱 Poland 🇵🇹 Portugal 🇷🇺 Russia 🇸🇮 Slovenia 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇨🇭 Switzerland Turkey (Türkiye) 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Change From Baseline to Week 105 in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score

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