Identifying biomarkers for early-onset Alzheimer's disease in mutation carriers
Dominantly Inherited Alzheimer Network (DIAN)
This study is trying to find early signs of Alzheimer's disease in people who carry a specific gene mutation to see how it affects their brain and body compared to those who don’t have the mutation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 26 sites (Jacksonville, Florida and 25 other locations) |
| Trial ID | NCT00869817 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on individuals with dominantly inherited Alzheimer's disease (AD) to identify biomarkers that may predict the onset of the disease. It aims to explore preclinical changes in biological fluids and neuroimaging in gene carriers compared to non-carriers. The study will investigate the progression of amyloid-beta 42 levels, amyloid deposition, cerebral metabolic activity, and structural changes in the brain. Participants will be recruited from an established international registry, including both symptomatic and asymptomatic individuals.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are children of individuals with known Alzheimer's mutations and are cognitively normal to mildly impaired.
Not a fit: Patients under 18 or those with medical or psychiatric illnesses that interfere with study participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to early detection and intervention strategies for individuals at risk of developing Alzheimer's disease.
How similar studies have performed: Other studies have shown promise in identifying biomarkers for Alzheimer's disease, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent obtained from participant and collateral source prior to any study-related procedures. * Aged 18 (inclusive) or older and the child of an affected individual (clinically or by testing) in a pedigree with a known mutation for ADAD. * Cognitively normal to very mild or mild cognitive impairment (CDR score range 0-1.0). Primary enrollment will focus on the recruitment of asymptomatic adult children who are more than 15 years younger than the estimated age of symptom onset. Enrollment of new participants with moderate cognitive impairment is allowed with the prior approval of the DIAN Coordinating Center. * Has two persons who are not their full-blooded siblings who can serve as collateral sources for the study. * Fluent in a language approved by the DIAN Coordinating Center at about the 6th grade level (international equivalent) or above. Exclusion Criteria: * Under age 18 * Medical or psychiatric illness that would interfere in completing initial and follow-up visits * Requires nursing home level care * Has no one who can serve as a study informant
Where this trial is running
Jacksonville, Florida and 25 other locations
- Mayo Clinic Jacksonville — Jacksonville, Florida, United States (Recruiting)
- Indiana University-Indiana Alzheimer Disease Center — Indianapolis, Indiana, United States (Recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Washington University in St. Louis School of Medicine — St Louis, Missouri, United States (Recruiting)
- Columbia University — New York, New York, United States (Suspended)
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
- Butler Hospital — Providence, Rhode Island, United States (Recruiting)
- University of Washington — Seattle, Washington, United States (Recruiting)
- Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia" (FLENI) Instituto de Investigaciones Neurológicas Raúl Correa — Buenos Aires, Argentina (Recruiting)
- Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI) — Salta, Argentina (Recruiting)
- Neuroscience Research Australia — Sydney, New South Wales, Australia (Recruiting)
- Mental Health Research Institute, University of Melbourne — Melbourne, Victoria, Australia (Suspended)
- Sir James McCusker Alzheimer's Disease Research Unit, Edith Cowan University — Perth, Western Australia, Australia (Recruiting)
- Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo — São Paulo, Brazil (Recruiting)
- McGill University Research Centre for Studies in Aging — Verdun, Quebec, Canada (Not_yet_recruiting)
- Grupo Neurociencias de Antioquia — Medellín, Colombia (Recruiting)
- German Center for Neurodegenerative Diseases (DZNE) Munich, and University Hospital Ludwig-Maximilians-Universitat (LMU) Munich — Munich, Germany (Recruiting)
- German Center for Neurodegenerative Diseases (DZNE) Tübingen and Hertie-Institute for Clinical Brain Research, University of Tübingen — Tübingen, Germany (Recruiting)
- Niigata University — Niigata, Japan (Recruiting)
- Osaka City University — Osaka, Japan (Suspended)
- Tokyo University — Tokyo, Japan (Recruiting)
- Instituto Nacional de Neurología y Neurocirugía "Manuel Velasco Suarez" — Mexico City, Mexico (Recruiting)
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
- Asan Medical Center — Seoul, Songpa-Gu, South Korea (Recruiting)
- Hospital Clinic Barcelona — Barcelona, Catalonia, Spain (Suspended)
- Institute of Neurology, Queen Square — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Eric McDade, DO — Washington University School of Medicine
- Study coordinator: Alisha Daniels, MD,MHA
- Phone: (314) 273-9057
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.