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 (NCT04623242) was part of the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) study, which looked at two experimental drugs — gantenerumab and solanezumab — in people who carry a rare genetic mutation that causes early-onset Alzheimer's disease. A total of 262 people took part across five groups: 52 received gantenerumab, 52 received solanezumab, 40 were mutation-carriers who received a placebo (an inactive treatment), 49 were non-carriers who received a placebo, and 69 were in an observational group. Not everyone finished the study — 39 completed in the gantenerumab group, 36 in the solanezumab group, 30 in the mutation-positive placebo group, and 26 in the mutation-negative placebo group. The reported data shows that the main thing being measured was a combined score from four thinking and memory tests, called the DIAN Multivariate Cognitive Endpoint (DIAN-MCE). This score was compared between each treatment group and the mutation-carrier placebo group — a ratio above 1.0 would suggest the treatment group scored higher on the combined tests relative to the placebo group. The reported ratio for gantenerumab compared to placebo was 1.063, and for solanezumab it was 1.255. For the secondary measures, the reported data shows scores on thinking and function scales recorded at multiple time points across both treatment and placebo groups. For example, on the CDR Sum of Boxes scale (where lower scores indicate better function, ranging from 0 to 18), gantenerumab participants had reported scores ranging from 0.74 to 4.61 across visits, compared to 0.44 to 5.76 for the mutation-positive placebo group. A brain imaging measure of amyloid (a protein associated with Alzheimer's disease) showed reported changes of -0.006, -0.106, and -0.334 for gantenerumab participants across three timepoints, compared to 0.103, 0.134, and 0.306 for the placebo group, where higher scores indicate a worse disease stage. Scores for solanezumab on similar measures were also reported across multiple visits, though what these numbers mean clinically was not explained in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 38683602) ↗
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, Completed
Who may 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 might be able to join this trial:
- You are between 18 and 80 years old
- You either know you carry a gene mutation that causes Alzheimer's disease, or you are unsure of your genetic status but have a family history of inherited (dominantly inherited) Alzheimer's disease
- You are within 15 years before or 10 years after the age when memory or thinking problems would be expected to begin (or actually began) in your family
- Your thinking and memory are either normal, mildly affected, or you have very mild dementia (as measured by a standard rating scale called the CDR, scoring 0 or 1)
- You can speak and understand one of the languages approved for this trial, and you have a reasonable level of general intellectual ability
- You are able to have an MRI scan, a lumbar puncture (spinal tap), a PET scan, and complete all other study tests and assessments
- If you are a woman who could become pregnant and your partner has not had a sterilisation procedure, you must agree to use an effective form of birth control throughout the trial
- You have good enough vision and hearing to complete all thinking and memory tests in the study
- You have a trusted person (such as a family member or close friend) who knows you well, can accurately describe your memory and daily functioning, and is willing to attend study visits to provide this information
Who may not be able to join:
- Your brain MRI shows signs of a significant abnormality unrelated to Alzheimer's disease
- You are currently dependent on alcohol or drugs, or have been within the past year
- You have a pacemaker, aneurysm clips, an artificial heart valve, ear implants, or any metal objects in your eyes, skin, or body that would make an MRI scan unsafe
- You have a significant history or current diagnosis of serious heart disease, liver or kidney problems, infection or immune system disorders, or hormonal/metabolic conditions
- You take blood-thinning medications, unless it is only a low dose of aspirin (325 mg or less)
- You have received a specific type of treatment targeting Alzheimer's-related proteins (monoclonal antibodies targeting beta amyloid) in the past six months
- You have had cancer in the last 5 years — though some skin cancers and early-stage prostate cancer with little or no progression over the past 2 years may still be eligible (confirm with trial site)
- You are currently pregnant, or your pregnancy test comes back positive, or you plan to become pregnant during the trial
- You are unable to complete all required study tests for any reason, including having metal implants that cannot be removed for MRI, needing ongoing blood-thinning medication, or being pregnant
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.
Contact this trial
Principal Investigator: Randall J Bateman, MD, Washington University School of Medicine
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
3 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Assess Cognitive Efficacy in Individuals With Mutations Causing Dominantly Inherited AD as Measured by the DIAN-Multivariate Cognitive Endpoint (DIAN-MCE);
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.