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Preventing dementia in individuals with a genetic risk for Alzheimer's disease

A Phase II/III Multicenter Randomized, Double-Blind, Placebo-Controlled Platform Trial of Potential Disease Modifying Therapies Utilizing Biomarker, Cognitive, and Clinical Endpoints in Dominantly Inherited Alzheimer's Disease

Phase2; Phase3 Interventional Washington University School of Medicine · NCT01760005

This study is testing new medications to see if they can help people with a genetic risk for early Alzheimer's disease by slowing down memory loss and other symptoms.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment490 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorWashington University School of Medicine Academic / other
Drugs / interventionsSolanezumab, gantenerumab
Locations38 sites (Birmingham, Alabama and 37 other locations)
Trial IDNCT01760005 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and effectiveness of investigational treatments for individuals at risk of early onset Alzheimer's disease due to genetic mutations. Participants will be recruited from the Dominantly Inherited Alzheimer Network and will undergo a series of assessments, including cognitive testing and imaging studies, to monitor disease progression and treatment response. The study will involve administering drugs such as Gantenerumab and Solanezumab, along with matching placebos, to determine their impact on cognitive decline and biomarkers associated with Alzheimer's disease.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 18-80 with a known Alzheimer's disease-causing mutation or those at risk due to family history.

Not a fit: Patients without a familial link to dominantly inherited Alzheimer's disease or those with advanced dementia may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new treatments that slow the progression of Alzheimer's disease in genetically predisposed individuals.

How similar studies have performed: Previous studies targeting genetic mutations associated with Alzheimer's have shown promise, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Between 18-80 years of age
* Individuals who know they have an Alzheimer's disease-causing mutation or are unaware of their genetic status and have dominantly inherited Alzheimer's disease (DIAD) mutation in their family.
* Are within -15 to + 10 years of the predicted or actual age of cognitive symptom onset. For Cognitive Run-In (CRI): includes participants who are younger than 15 years prior to the expected age of cognitive symptom onset, in addition to those 15 years younger and no more than 10 years older than expected or actual age of cognitive symptom onset.
* Cognitively normal or with mild cognitive impairment or mild dementia, Clinical Dementia Rating (CDR) of 0-1 (inclusive)
* Fluency in DIAN-TU trial approved language and evidence of adequate premorbid intellectual functioning
* Able to undergo Magnetic Resonance Imaging (MRI), Lumbar Puncture (LP), Positron Emission Tomography (PET), and complete all study related testing and evaluations.
* For women of childbearing potential, if partner is not sterilized, subject must agree to use effective contraceptive measures (hormonal contraception, intra-uterine device, sexual abstinence, barrier method with spermicide).
* Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments.
* Has a Study Partner who in the investigator's judgment is able to provide accurate information as to the subject's cognitive and functional abilities, who agrees to provide information at the study visits which require informant input for scale completion.

Exclusion Criteria:

* History or presence of brain MRI scans indicative of any other significant abnormality
* Alcohol or drug dependence currently or within the past 1 year
* Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin or body which would preclude MRI scan.
* History or presence of clinically significant cardiovascular disease, hepatic/renal disorders, infectious disease or immune disorder, or metabolic/endocrine disorders
* Anticoagulants except low dose (≤ 325 mg) aspirin.
* Have been exposed to a monoclonal antibody targeting beta amyloid peptide within the past six months.
* History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years.
* Positive urine or serum pregnancy test or plans or desires to become pregnant during the course of the trial.
* Subjects unable to complete all study related testing, including implanted metal that cannot be removed for MRI scanning, required anticoagulation and pregnancy.

Where this trial is running

Birmingham, Alabama and 37 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Alzheimers DiseaseDementiaAlzheimers Disease, FamilialAlzheimer'sAlzheimer's DiseaseMutationGenetic MutationDominantly Inherited Alzheimer's Disease
Last reviewed 2026-06-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.