Early Identification of Markers in Alzheimer's Families / ALFA (ALFA Cohort)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02485730|
Recruitment Status : Recruiting
First Posted : June 30, 2015
Last Update Posted : July 21, 2020
|Condition or disease|
The natural history of AD includes an asymptomatic or preclinical phase characterized by pathological cerebral alterations without any evident symptoms of the disease. The beginning of the preclinical phase can be detected using a series of biological and neuroimaging markers that indicate the presence of Aβ deposition in the brain. A variety of factors such as inflammation, genetic load (e.g., APOE4), diet, cardiovascular risk, sleep disorders and cognitive reserve, produced by endogenous or exogenous factors, vary among individuals and may determine the beginning and evolution of the preclinical phase of the disease. It is possible to identify subclinical, biological, cognitive and neuroimaging changes, in the AD preclinical phase. The longitudinal study of intra-individual changes will be more sensitive than cross-sectional inter-individual studies to detect the cognitive evolution during the AD preclinical phase. Similarly, it would be possible to identify factors in subjects at the preclinical phase that will influence their evolution to the clinical stage of the disease.
The study will start with a screening of 3.000 recruited volunteers (NCT01835717) complying as much as possible with study selection criteria and perfectly aware of the study needs.
The selected 400 participants fulfilling the inclusion criteria will undergo detailed phenotyping consisting in: clinical history, AD family history, full cognitive evaluation, cognitive reserve determination, CSF sample collection, blood and urine sample collection, neuroimaging (MRI), quality of life and habits of life questionnaires (physical activity, diet, sleeping habits, social activity, toxics habits, pollution exposure).
The longitudinal study will consist in a every 3-year follow-up visit in which the participant will undergo a review of the clinical history data, a full cognitive evaluation, neuroimaging (MRI), samples collection (blood, urine, CSF) and update of the life habits changes.
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Cohort Study for Early Identification of Markers in Cognitively Healthy Family Members of Patients With Alzheimer's Disease|
|Actual Study Start Date :||October 25, 2016|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||January 2024|
Adult children of AD patient
Cognitively healthy adult children of AD patient: First-degree descendant of an AD patient (following diagnosis as define in protocol) from 45 to 64 years old.
- Change from preclinical phase of AD to Mild Cognitive Impairment. [ Time Frame: Every 3 years, from date of inclusion until the date of first documented progression, fulfilling mild cognitive impairment criteria, or date of death from any cause, whichever came first, assessed up to 12 years. ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02485730
|Contact: Karine Fauria, PhD||(+34) 93 316 09 firstname.lastname@example.org|
|Contact: Carolina Minguillon, PhD||(+34) 93 316 09 email@example.com|
|Barcelonabeta Brain Research Center||Recruiting|
|Barcelona, Spain, 08005|
|Contact: Carolina Minguillon, PhD +34933160990 firstname.lastname@example.org|
|Principal Investigator:||Jose Luis Molinuevo, MD, PhD||Scientific Director|