Early Identification of Markers in Alzheimer's Families / ALFA

NCT02485730 | Active Not Recruiting

• 1 other identifier: ALFA-FPM-0311
• Study Type: observational
• Target: 419
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Keywords

Prevention; Cohort Analysis; Healthy Participants

Outcome Measures

Primary Outcomes (1)

• Change from preclinical phase of AD to Mild Cognitive Impairment.

  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.

Study Arms (1)

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.

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Family history of monogenic AD.
• Not willing to undergo one or more of the tests and procedures described in the protocol at baseline.

Sponsors & Collaborators

• Barcelonabeta Brain Research Center, Pasqual Maragall Foundation: lead
• Obra Social La Caixa, Spain: collaborator

Study Sites (1)

Barcelonabeta Brain Research Center

Barcelona, 08005, Spain

Location

Related Publications (9)

• Lazaro I, Brugulat-Serrat A, Suarez-Calvet M, Fauria K, Minguillon C, Gispert JD, Molinuevo JL, Harris WS, Sanchez-Benavides G, Grau-Rivera O, Sala-Vila A; ALFA study. Red blood cell omega-3 status and longitudinal cognition in individuals at risk of Alzheimer disease. J Nutr. 2025 Dec;155(12):4514-4522. doi: 10.1016/j.tjnut.2025.09.032. Epub 2025 Sep 27.

  PMID: 41022152 DERIVED

• Akinci M, Aguilar-Dominguez P, Palpatzis E, Shekari M, Garcia-Prat M, Deulofeu C, Fauria K, Garcia-Aymerich J, Gispert JD, Suarez-Calvet M, Grau-Rivera O, Sanchez-Benavides G, Arenaza-Urquijo EM; ALFA study. Physical activity changes during midlife link to brain integrity and amyloid burden. Alzheimers Dement. 2025 May;21(5):e70007. doi: 10.1002/alz.70007.

  PMID: 40304268 DERIVED

• Brugulat-Serrat A, Sanchez-Benavides G, Cacciaglia R, Salvado G, Shekari M, Collij LE, Buckley C, van Berckel BNM, Perissinotti A, Ninerola-Baizan A, Mila-Aloma M, Vilor-Tejedor N, Operto G, Falcon C, Grau-Rivera O, Arenaza-Urquijo EM, Minguillon C, Fauria K, Molinuevo JL, Suarez-Calvet M, Gispert JD; ALFA Study. APOE-epsilon4 modulates the association between regional amyloid deposition and cognitive performance in cognitively unimpaired middle-aged individuals. EJNMMI Res. 2023 Mar 1;13(1):18. doi: 10.1186/s13550-023-00967-6.

  PMID: 36856866 DERIVED

• Akinci M, Pena-Gomez C, Operto G, Fuentes-Julian S, Deulofeu C, Sanchez-Benavides G, Mila-Aloma M, Grau-Rivera O, Gramunt N, Navarro A, Minguillon C, Fauria K, Suridjan I, Kollmorgen G, Bayfield A, Blennow K, Zetterberg H, Molinuevo JL, Suarez-Calvet M, Gispert JD, Arenaza-Urquijo EM; ALFA Study. Prepandemic Alzheimer Disease Biomarkers and Anxious-Depressive Symptoms During the COVID-19 Confinement in Cognitively Unimpaired Adults. Neurology. 2022 Oct 4;99(14):e1486-e1498. doi: 10.1212/WNL.0000000000200948. Epub 2022 Aug 2.

  PMID: 35918160 DERIVED

• Mila-Aloma M, Brinkmalm A, Ashton NJ, Kvartsberg H, Shekari M, Operto G, Salvado G, Falcon C, Gispert JD, Vilor-Tejedor N, Arenaza-Urquijo EM, Grau-Rivera O, Sala-Vila A, Sanchez-Benavides G, Gonzalez-de-Echavarri JM, Minguillon C, Fauria K, Ninerola-Baizan A, Perissinotti A, Kollmorgen G, Suridjan I, Zetterberg H, Molinuevo JL, Blennow K, Suarez-Calvet M; ALFA Study. CSF Synaptic Biomarkers in the Preclinical Stage of Alzheimer Disease and Their Association With MRI and PET: A Cross-sectional Study. Neurology. 2021 Nov 23;97(21):e2065-e2078. doi: 10.1212/WNL.0000000000012853. Epub 2021 Sep 23.

  PMID: 34556565 DERIVED

• Mila-Aloma M, Shekari M, Salvado G, Gispert JD, Arenaza-Urquijo EM, Operto G, Falcon C, Vilor-Tejedor N, Grau-Rivera O, Sala-Vila A, Sanchez-Benavides G, Gonzalez-de-Echavarri JM, Minguillon C, Fauria K, Ninerola-Baizan A, Perissinotti A, Simon M, Kollmorgen G, Zetterberg H, Blennow K, Suarez-Calvet M, Molinuevo JL; ALFA study. Cognitively unimpaired individuals with a low burden of Abeta pathology have a distinct CSF biomarker profile. Alzheimers Res Ther. 2021 Jul 27;13(1):134. doi: 10.1186/s13195-021-00863-y.

  PMID: 34315519 DERIVED

• Grau-Rivera O, Navalpotro-Gomez I, Sanchez-Benavides G, Suarez-Calvet M, Mila-Aloma M, Arenaza-Urquijo EM, Salvado G, Sala-Vila A, Shekari M, Gonzalez-de-Echavarri JM, Minguillon C, Ninerola-Baizan A, Perissinotti A, Simon M, Kollmorgen G, Zetterberg H, Blennow K, Gispert JD, Molinuevo JL; ALFA Study. Association of weight change with cerebrospinal fluid biomarkers and amyloid positron emission tomography in preclinical Alzheimer's disease. Alzheimers Res Ther. 2021 Feb 17;13(1):46. doi: 10.1186/s13195-021-00781-z.

  PMID: 33597012 DERIVED

• Arenaza-Urquijo EM, Salvado G, Operto G, Minguillon C, Sanchez-Benavides G, Crous-Bou M, Grau-Rivera O, Sala-Vila A, Falcon C, Suarez-Calvet M, Zetterberg H, Blennow K, Gispert JD, Molinuevo JL; ALFA Study. Association of years to parent's sporadic onset and risk factors with neural integrity and Alzheimer biomarkers. Neurology. 2020 Oct 13;95(15):e2065-e2074. doi: 10.1212/WNL.0000000000010527. Epub 2020 Jul 31.

  PMID: 32737076 DERIVED

• Salvado G, Molinuevo JL, Brugulat-Serrat A, Falcon C, Grau-Rivera O, Suarez-Calvet M, Pavia J, Ninerola-Baizan A, Perissinotti A, Lomena F, Minguillon C, Fauria K, Zetterberg H, Blennow K, Gispert JD; Alzheimer's Disease Neuroimaging Initiative, for the ALFA Study. Centiloid cut-off values for optimal agreement between PET and CSF core AD biomarkers. Alzheimers Res Ther. 2019 Mar 21;11(1):27. doi: 10.1186/s13195-019-0478-z.

  PMID: 30902090 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, urine and CSF samples collection and analysis.

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jose Luis Molinuevo, MD, PhD

  Scientific Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: June 30, 2015
• Study Start: October 25, 2016
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

ES (1)