Alzheimer's DiseaseALFA CohortNCT02485730
Early Identification of Markers in Alzheimer's Families / ALFA
An observational study of Alzheimer's Disease, run by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- How many people
- 419 participants
- Where
- 1 siteSpain
- Study dates
- 25 Oct 2016to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cohort Study for Early Identification of Markers in Cognitively Healthy Family Members of Patients With Alzheimer's Disease
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.
Read the 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.
- Conditions
- Alzheimer's Disease
- Keywords
- Prevention, Cohort Analysis, Healthy Participants
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from preclinical phase of AD to Mild Cognitive Impairment.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study start25 Oct 2016
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 419 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- La Caixa Foundation
- Responsible party
- Sponsor
- Investigators
- Jose Luis Molinuevo, MD, PhD, Principal investigator, Scientific Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485730
- Sponsor's protocol ID
- ALFA-FPM-0311
- Acronym
- ALFA Cohort
- Status last verified
- May 2025
- First submitted
- 10 Jun 2015
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Vilor-Tejedor N, Rodriguez-Fernandez B, Genius P, Fernandez-Bonet A, Gonzalez-Escalante A, Brugulat-Serrat A, Sanchez-Benavides G, Cumplido-Mayoral I, Minguillon C, Cirach M, Nieuwenhuijsen M, Kollmorgen G, Quijano-Rubio C, Zetterberg H, Blennow K, Navarro A, Suarez-Calvet M, Gispert JD; ALFA study. Air pollution is associated with sex-specific longitudinal changes in astrocytic and neuroinflammatory processes linked to cognitive decline in Alzheimer's disease at-risk individuals. Alzheimers Dement. 2026 Oct;22(10):e71837. doi: 10.1002/alz.71837.
PubMed 42872554Lazaro 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.
PubMed 41022152Akinci 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.
PubMed 40304268Brugulat-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.
PubMed 36856866Akinci 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.
PubMed 35918160Mila-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.
PubMed 34556565Mila-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.
PubMed 34315519Grau-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.
PubMed 33597012Arenaza-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.
PubMed 32737076Salvado 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.
PubMed 30902090
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study for Early Identification of Markers in Cognitively Healthy Family Members of Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT02485730
- Acronym / sponsor ID
- ALFA Cohort / ALFA-FPM-0311
- Conditions
- Alzheimer's Disease
- Keywords
- Prevention, Cohort Analysis, Healthy Participants
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 419 participants (actual)
- Lead sponsor
- Barcelonabeta Brain Research Center, Pasqual Maragall FoundationUniversity, hospital or other
- Collaborators
- La Caixa Foundation
- Study start
- 25 Oct 2016 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Derived from this study: PubMed 42872554Vilor-Tejedor N, Rodriguez-Fernandez B, Genius P, Fernandez-Bonet A, Gonzalez-Escalante A, Brugulat-Serrat A, Sanchez-Benavides G, Cumplido-Mayoral I, Minguillon C, Cirach M, Nieuwenhuijsen M, Kollmorgen G, Quijano-Rubio C, Zetterberg H, Blennow K, Navarro A, Suarez-Calvet M, Gispert JD; ALFA study. Air pollution is associated with sex-specific longitudinal changes in astrocytic and neuroinflammatory processes linked to cognitive decline in Alzheimer's disease at-risk individuals. Alzheimers Dement. 2026 Oct;22(10):e71837. doi: 10.1002/alz.71837.
- Derived from this study: PubMed 41022152Lazaro 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.
- Derived from this study: PubMed 40304268Akinci 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.
- Derived from this study: PubMed 36856866Brugulat-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.
- Derived from this study: PubMed 35918160Akinci 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.
- Derived from this study: PubMed 34556565Mila-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.
- Derived from this study: PubMed 34315519Mila-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.
- Derived from this study: PubMed 33597012Grau-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.
- Derived from this study: PubMed 32737076Arenaza-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.
- Derived from this study: PubMed 30902090Salvado 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Luis Molinuevo, MD, PhD principal investigator
Scientific Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease, run by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02485730, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.