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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. Read our disclaimer for details. Identifier: NCT02485730
Recruitment Status : Active, not recruiting
First Posted : June 30, 2015
Last Update Posted : March 31, 2023
Obra Social La Caixa, Spain
Information provided by (Responsible Party):
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Brief Summary:
The ALFA study is a long term, prospective, observational study of AD patients' adult children aimed at studying and characterizing key physio-pathological features of the preclinical phase of AD.

Condition or disease
Alzheimer's Disease

Detailed Description:

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.

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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

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.

Primary Outcome Measures :
  1. 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
Whole blood, urine and CSF samples collection and analysis.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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
Study Population
Offsprings of subjects diagnosed of probable AD before reaching 75 years of age, according to McKhann et al. [McKhann et al., 1984] criteria, will be selected from spontaneous volunteers and Alzheimer's patients associations members.

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02485730

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Barcelonabeta Brain Research Center
Barcelona, Spain, 08005
Sponsors and Collaborators
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Obra Social La Caixa, Spain
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Principal Investigator: Jose Luis Molinuevo, MD, PhD Scientific Director
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation 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
Keywords provided by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation:
Cohort Analysis
Healthy Participants
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders