Phase 3 Alzheimer's Disease Trial, Terminated NCT05256134 Sponsor: Hoffmann-La Roche 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 (NCT05256134) enrolled 25 people in total — 12 in the placebo group and 13 in the gantenerumab group. Gantenerumab is a medicine that was being investigated for Alzheimer's disease. The trial was measuring changes in thinking and memory abilities over time, as well as how long it took for participants' condition to progress. Notably, the reported data shows that none of the participants completed the study — all 25 are listed as having not completed it — which is important context for interpreting the numbers below. The reported data shows the following for the primary outcome, which was a combined score across five memory and thinking tests (called the PACC-5, where a higher score means better performance): the placebo group's score changed by −0.052 and the gantenerumab group's score changed by −0.119 from their starting point, meaning both groups showed a small decline on average. For the secondary outcomes measuring daily living abilities (A-IADL-Q-SV, where higher is better), the placebo group changed by −1.3 and the gantenerumab group by −0.4. For a self-reported memory difficulties questionnaire (CFIa participant version, where higher means more difficulty), the placebo group changed by +0.3 and the gantenerumab group by +0.9. The study partner version of the same questionnaire showed −0.8 for placebo and +0.2 for gantenerumab. The two outcomes measuring time to disease progression were listed as "not available" — meaning those figures were not reported in the data submitted. 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 3 Alzheimer's Disease Trial, Terminated

NCT05256134
Terminated Phase 3 🇦🇺 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 willing and able to take part in all parts of the study, including memory and thinking tests, physical and brain exams, MRI scans, spinal fluid collection, genetic testing, and PET scans.
  • Your thinking and memory are currently normal, based on specific screening tests used by the study team.
  • Tests show that you have a build-up of a protein called amyloid in your brain.
  • You have a trusted person in your life (such as a family member or close friend) who is available to take part in the study alongside you as a "study partner."
  • You are fluent in the language used for the tests at the study location.
  • You have good enough vision and hearing to complete thinking and memory tests (glasses and hearing aids are allowed).
  • You agree not to join any other experimental treatment studies while in this trial.
  • If you are a woman who could become pregnant, you agree to either avoid heterosexual sex or use highly effective birth control during the study and for at least 17 weeks after your last dose of the study treatment.

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 brain or nerve condition (other than Alzheimer's disease) that could affect your thinking or memory.
  • You have already been diagnosed with mild memory problems, early Alzheimer's disease, or any form of dementia.
  • You have a history of abnormal blood vessels, aneurysms, or bleeding in the brain.
  • You have a history of a condition called posterior reversible encephalopathy syndrome (confirm with trial site).
  • You had a stroke with symptoms, or a mini-stroke (TIA), within the past 12 months.
  • You have had a serious brain injury in the past that caused lasting damage to your brain or nervous system.
  • You have or have had a growth or mass inside your skull (such as a brain tumor) that could affect thinking or brain function.
  • You have or have had an infection that affected your brain function, such as HIV, syphilis, Lyme disease affecting the nervous system, or meningitis/encephalitis.
  • You have a history of major depression, schizophrenia, schizoaffective disorder, or bipolar disorder.
  • You are considered to be at risk of suicide.
  • You have a history of alcohol or drug abuse or dependence.
  • You have a history of significant problems with blood vessels throughout your body, irregular heart rhythm (atrial fibrillation), or heart failure.
  • You had a serious heart event (such as a heart attack) within the past year.
  • Your blood pressure is not controlled.
  • Your kidneys are not working well enough (based on a specific blood test result).
  • You have unexplained significant liver problems.
  • You have an untreated or inadequately treated HIV, hepatitis B, or hepatitis C infection.
  • You have an autoimmune condition that could progressively affect your brain or thinking.
  • You are currently taking medications that suppress or significantly alter your immune system.
  • You currently have COVID-19.
  • Tests show you are deficient in folic acid or vitamin B-12.
  • You have received certain antibody-based treatments aimed at preventing memory decline within the past year.
  • You have taken part in another experimental drug study within 6 months (or 5 half-lives of that drug, whichever is longer) before screening.
  • You are currently taking antipsychotic or neuroleptic medications.
  • You have taken blood-thinning (anticoagulant) medications within the past 3 months, or plan to start them before the study begins.
  • You have previously taken certain Alzheimer's medications known as cholinesterase inhibitors or NMDA receptor antagonists (confirm with trial site).
  • You are pregnant, breastfeeding, or planning to become pregnant during the study or within 17 weeks after your last dose of the study drug.
  • You have a blood clotting disorder.
  • You have had a severe allergic reaction to antibody-based medications similar to the one used in this study.
  • You currently live in a nursing home or long-term care facility.

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 31 July 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

Principal Investigator: Clinical Trials, Hoffmann-La Roche

Australian sites

KaRa Institute of Neurological Diseases, Macquarie Park, New South Wales
Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre, Heidelberg West, Victoria
Australian Alzheimer's Research Foundation, 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
Terminated
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
19 April 2022
Est. completion
13 March 2023

Where this trial was run

🇦🇷 Argentina 🇦🇺 Australia 🇨🇦 Canada 🇮🇹 Italy 🇵🇱 Poland 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇬🇧 United Kingdom 🇺🇸 United States

These are the locations recorded on the registry, including 3 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

Change From Baseline in PACC-5 Score

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: 31 July 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