Early Identification of Markers in Alzheimer's Families / ALFA (ALFA Cohort)
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| ClinicalTrials.gov Identifier: NCT02485730 |
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Recruitment Status :
Active, not recruiting
First Posted : June 30, 2015
Last Update Posted : March 31, 2023
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| Condition or disease |
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| Alzheimer's 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 |
| Actual Enrollment : | 419 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| 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, 2024 |
| Estimated Study Completion Date : | December 31, 2025 |
| Group/Cohort |
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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.
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- 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
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| Ages Eligible for Study: | 45 Years to 64 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Adult children of AD patient: First-degree descendant of an AD patient (following diagnosis as define in protocol).
- Age: 45 to 64 years old.
- Long-term commitment to the study: baseline and follow-up visits. Potential participants have to agree to undergo to all the procedures described in the protocol.
Exclusion Criteria:
- Cognitive impairment: to be included the participant must show no signs of objective cognitive impairment.
- Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol.
- Illiteracy or functional illiteracy.
- Any contraindication to any test or procedure at the time of study inclusion.
- Family history of monogenic AD.
- Not willing to undergo one or more of the tests and procedures described in the protocol at baseline.
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
| Spain | |
| Barcelonabeta Brain Research Center | |
| Barcelona, Spain, 08005 | |
| Principal Investigator: | Jose Luis Molinuevo, MD, PhD | Scientific Director |
| Responsible Party: | Barcelonabeta Brain Research Center, Pasqual Maragall Foundation |
| ClinicalTrials.gov Identifier: | NCT02485730 |
| Other Study ID Numbers: |
ALFA-FPM-0311 |
| First Posted: | June 30, 2015 Key Record Dates |
| Last Update Posted: | March 31, 2023 |
| Last Verified: | November 2022 |
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Prevention Cohort Analysis Healthy Participants |
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Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |