NCT02685969

Brief Summary

Study to understand factors related with the preclinical stages of Alzheimer's Disease and investigate markers that predict its progression. Cross-sectional and single arm study performed on a subgroup of individuals recruited in the ALFA project. Study without therapeutic interest for the research participants (440 participants of the ALFA project who have been selected for being cognitively healthy and in their vast majority are direct descendants of patients diagnosed with Alzheimer's Disease). Each study candidate will be selected from the ALFA project (STUDY 45-65 FPM/2012) according to their clinical characteristics, their compliance to selection criteria and their desire to participate in this study. After signing this study's specific informed consent form, the neuropsychological screening and the brain MRI acquisition will be performed. Once all inclusion criteria are checked, the PET scans with 18F-Flutemetamol and 18F-FDG will be performed

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
570

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Mar 2017Dec 2027

First Submitted

Initial submission to the registry

February 15, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 19, 2016

Completed
1 year until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

9.8 years

First QC Date

February 15, 2016

Last Update Submit

May 27, 2025

Conditions

Alzheimer's Disease

Keywords

PreventionPositron Emission Tomography

Outcome Measures

Primary Outcomes (1)

  • Prevalence of a positive 18F-Flutemetamol scan

    To study the prevalence of a positive 18F-Flutemetamol PET scan in a cohort of cognitively healthy, at-risk of developing AD participants.

    Baseline

Secondary Outcomes (1)

  • Prevalence of the different stages of preclinical AD according to the NIA-AA criteria

    Baseline

Study Arms (1)

18F-Flutemetamol & 18F-FDG PET scans

All study participants will be assessed by PET scan with 18F-Flutemetamol \& 18F-FDG PET scans.

Procedure: 18F-Flutemetamol & 18F-FDG

Interventions

18F-Flutemetamol & 18F-FDGPROCEDURE

Characterization of cerebral amyloid deposition with 18F-Flutemetamol PET and glucose metabolism 18F-FDG PET.

18F-Flutemetamol & 18F-FDG PET scans

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 440 participants enrolled in the ALFA project (STUDY 45-65 FPM/2012) will be selected and physiologically characterized with 18F-Flutemetamol and 18F-FDG PET scans.

You may qualify if:

  • To sign the study informed consent form approved by the corresponding authorities.
  • Men and women enrolled in the ALFA project (STUDY 45-65 FPM/2012).
  • Cognition within psychometrically normal ranges: MMSE (Mini Mental State Examination ≥26 and Semantic Fluency (animals) ≥12.
  • Score of 0 in the CDR scale (Clinical Dementia Rating).
  • Good knowledge of the language and being literate.
  • Female participants should be post-menopausal or present a negative pregnancy test at the moment of PET acquisition.

You may not qualify if:

  • Present cognitive impairment.
  • Presence of clinically relevant psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV-TR) criteria: major depressive disorder, generalized anxiety disorder, schizophrenia or bipolar disorder.
  • Individuals with visual and/or hearing impairment.
  • History of encephalitis, ictus or seizures excluding feverish convulsions during childhood.
  • Severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumor (metastasis/brain cancer) as verified by magnetic resonance imaging (MRI).
  • Any contraindication to MRI acquisition, (i.e., metal implants) or phobia to performing the scan as determined by the onsite physician.
  • Previous participation in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening and/or administration of a radiopharmaceutical within 10 radioactive half-lives prior to study drug administration in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BarcelonaBeta Brain Research Center

Barcelona, Catalonia, 08005, Spain

RECRUITING

Related Publications (3)

  • 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: 36856866DERIVED

  • 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: 33597012DERIVED

  • 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: 30902090DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

flutemetamolFluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Jose Luis Molinuevo, MD, PhD

    Scientific Director

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karine Fauria, PhD

CONTACT

933160990kfauria@fpmaragall.org

Carolina Herrero

CONTACT

933160990cherrero@fpmaragall.org

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2016

First Posted

February 19, 2016

Study Start

March 1, 2017

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

May 31, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)