Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation.
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Alzheimers Disease, Dementia, Alzheimers Disease, Familial
In brief
The purpose of this study is to assess the safety, tolerability, biomarker and cognitive efficacy of investigational products in subjects who are known to have an Alzheimer's disease-causing mutation by determining if treatment with the study drug slows the rate of progression of cognitive impairment and improves disease-related biomarkers. This is an analysis study for an MPRP: DIAN-TU-001 Master NCT01760005
Key facts
- Study ID
- NCT04623242
- Run by
- Washington University School of Medicine
- People needed
- 194
- Starts
- 2012-12-01
- Expected to finish
- 2020-03-06
- Last updated by the study team
- 2022-09-22
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
- 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.
You may not qualify if…
- 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 it is running
- University of Alabama in Birmingham — Birmingham, Alabama, United States
- University of California San Diego Medical Center — La Jolla, California, United States
- Yale University School of Medicine — New Haven, Connecticut, United States
- Emory University — Atlanta, Georgia, United States
- Indiana University School of Medicine — Indianapolis, Indiana, United States
- Washington University in St. Louis — St Louis, Missouri, United States
- Columbia University — New York, New York, United States
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States
- Butler Hospital — Providence, Rhode Island, United States
- University of Washington — Seattle, Washington, United States
- Neuroscience Research Australia — Randwick, New South Wales, Australia
- Mental Health Research Institute — Melbourne, Victoria, Australia
- The McCuster Foundation of Alzheimer's Disease Research — Nedlands, Western Australia, Australia
- UBC Hospital — Vancouver, British Columbia, Canada
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
- McGill Center for Studies in Aging — Verdun, Quebec, Canada
- CHU de Toulouse - Hôpital Purpan — Toulouse, Haute Garonne, France
- Hopital Roger Salengro - CHU Lille — Lille, Nord, France
- Groupe Hospitalier Pitie-Salpetriere — Paris, Paris, France
- Hopital Neurologique Pierre Wertheimer — Bron, Rhone, France
- CHU de Rouen - Hôpital Charles Nicolle — Rouen, Seine Maritime, France
- St Vincent's University Hospital — Dublin, Ireland
- University of Puerto Rico, School of Medicine — San Juan, Puerto Rico
- Hospital Clínic I Provincial de Barcelona — Barcelona, Spain
- The National Hospital for Neurology and Neurosurgery — London, Greater London, United Kingdom
Full record on ClinicalTrials.gov
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