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NCT05256134
NCT05256134
Who may be able to join
Who might be able to join this trial:
- 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:
- 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.
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
19 April 2022
Est. completion
13 March 2023
Where this trial is recruiting
🇦🇷 Argentina
🇦🇺 Australia
🇨🇦 Canada
🇮🇹 Italy
🇵🇱 Poland
🇰🇷 South Korea
🇪🇸 Spain
🇸🇪 Sweden
🇬🇧 United Kingdom
🇺🇸 United States
3 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Change From Baseline in PACC-5 Score
Can't join this trial?
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.