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Early Identification of Markers in Alzheimer's Families / ALFA (ALFA Cohort)

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ClinicalTrials.gov Identifier: NCT02485730
Recruitment Status : Recruiting
First Posted : June 30, 2015
Last Update Posted : July 21, 2020
Sponsor:
Collaborator:
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
Estimated Enrollment : 400 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, 2020
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Group/Cohort
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

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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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02485730


Contacts
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Contact: Karine Fauria, PhD (+34) 93 316 09 90 kfauria@fpmaragall.org
Contact: Carolina Minguillon, PhD (+34) 93 316 09 90 cminguillon@fpmaragall.org

Locations
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Spain
Barcelonabeta Brain Research Center Recruiting
Barcelona, Spain, 08005
Contact: Carolina Minguillon, PhD    +34933160990    cminguillon@fpmaragall.org   
Sponsors and Collaborators
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Obra Social La Caixa, Spain
Investigators
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Principal Investigator: Jose Luis Molinuevo, MD, PhD Scientific Director
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: July 21, 2020
Last Verified: July 2020
Keywords provided by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation:
Prevention
Cohort Analysis
Healthy Participants
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders