Back to Alzheimers Disease

NCT01524887

NCT01524887
Terminated Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You are between 50 and 89 years old (inclusive)
  • You (or your legal representative) are able to give written consent to take part
  • You have a caregiver who is willing and able to give written consent and help support your participation
  • You have been diagnosed with Probable Alzheimer's Disease according to specific recognised medical criteria
  • Your Alzheimer's is mild to moderate in severity, based on a standard memory test score between 16 and 26
  • You have had a brain scan (CT or MRI) after your symptoms began that is consistent with an Alzheimer's diagnosis
  • You are willing and able to follow the study schedule, including attending infusions and tests, and have adequate vision and hearing to do so
  • You have been on stable, approved Alzheimer's medication(s) for at least 12 weeks before joining, and are not taking two cholinesterase inhibitor medications at the same time (confirm with trial site)
  • You have suitable veins for repeated blood draws and infusions
  • If you take medications that affect mood, behaviour, or brain activity (such as antidepressants, antipsychotics, or anti-anxiety drugs), you have been on a stable dose for at least 6 weeks before joining
  • If you are a woman who could become pregnant, you have a negative pregnancy test before joining and agree to use reliable contraception throughout the study
  • If you have a coronary artery stent, you have received written clearance from a heart specialist confirming the treatment is safe for you (confirm with trial site)
  • If you have a blood vessel stent elsewhere in your body, you have received written clearance from a vascular surgeon confirming the treatment is safe for you (confirm with trial site)

Who may not be able to join:

  • You have a type of dementia other than Probable Alzheimer's Disease, such as vascular dementia, Lewy body dementia, or dementia linked to Parkinson's disease or other conditions
  • You currently live in a skilled nursing facility
  • You are unable to have an MRI scan — for example, because you have a non-MRI-compatible pacemaker, severe claustrophobia, or certain metal implants in your body
  • You have significant heart failure with notable symptoms (confirm with trial site)
  • You currently have an irregular heart rhythm (atrial fibrillation), chest pain at rest, or have had a heart attack in the past 12 months
  • You have uncontrolled high blood pressure (above certain levels even after repeated measurements)
  • You have had a blood clot or clot-related event in the past 12 months
  • You have a known history of a condition that makes your blood clot too easily (confirm with trial site)
  • You have had bleeding inside the brain in the past 5 years
  • Your MRI scan shows certain types of brain abnormalities, such as more than 4 small bleeds, a stroke, significant white matter damage, or other specific findings (confirm with trial site)
  • You have had a head injury with loss of consciousness, bruising of the brain, or an open head wound in the past 12 months
  • You have a seizure disorder that is not well controlled, meaning you have had two or more seizures in a year despite treatment
  • Your score on a specific memory and thinking test (Modified Hachinski) is above 4 at screening (confirm with trial site)
  • You have had cancer in the past 5 years, with some exceptions such as certain treated skin cancers or cervical carcinoma in situ
  • You have an active autoimmune or immune-related neurological condition
  • You have uncontrolled major depression, psychosis, or another serious mental health condition
  • You have poorly controlled diabetes, based on a specific blood test result (HbA1c of 6.5% or above)
  • Your kidneys are not functioning well enough, based on a specific calculation (confirm with trial site)
  • You have a known untreated vitamin B12 deficiency within the past 6 months, or a significantly low vitamin B12 level at the time of screening
  • Certain blood test results are outside acceptable ranges, including liver enzyme levels, signs of significant anaemia, low white blood cell count, low platelet count, or high total protein (confirm with trial site)
  • You have tested positive for hepatitis B, hepatitis C, or HIV
  • You have a deficiency of a

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
Baxalta now part of Shire
Registry
clinicaltrials_gov
Start date
23 January 2012
Est. completion
16 July 2013

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇨🇦 Canada 🇯🇵 Japan 🇵🇱 Poland 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Change From Baseline to Month 18 in Cognitive Subscale of the Alzheimer´s Disease Assessment Scale (ADAS-Cog); Change From Baseline to Month 18 in Alzheimer´s Disease Cooperative Study (ADCS)-Activities of Daily Living (ADL) Inventory

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