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Healthy IndividualsNCT01835717

Study for Cognitive and Genetic Characterization of a 45-65 Years Old Population

An observational study of Healthy Individuals, run by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Before Alzheimer's disease (AD) clinical symptoms appear, there is a long period when changes in the brain occur. In this long asymptomatic period or preclinical phase, studies with populations at risk of developing AD have shown cognitive differences compared to control groups without such risk. Read more about this study

Who is it for?
Ages 45 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Individuals
How many people
2,743 participants
Where
1 siteSpain
Study dates
Apr 2013to 31 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Cognitive normal men and woman aged 45-75 years

Who may be able to join

  • Men and women, aged between 45 and 75 years
  • Spanish and/or Catalan speakers
  • Agreement with the study procedures and tests:
  • Clinical Interview and questionnaires associated to risk factors
  • Cognitive tests
  • Blood sample extraction for DNA analysis
  • Close relative involvement for functional evaluation of the volunteer
  • Signature of informed consent

Who cannot join

  • Cognitive impairment: MMSE <26, o MIS <6, or orientation subtest of the Barcelona Test II <68, o category fluency (animals) <12
  • Functional status impairment: CDR > 0
  • Severe auditory and/or visual impairment
  • Neurodevelopmental and/or psychomotor disorder
  • Significant diseases that could currently interfere with cognition: renal failure on hemodialysis, liver cirrhosis, chronic lung disease with oxygen therapy, solid organ transplantation, fibromyalgia, active cancer in treatment or any other disease the investigator considers could affect the participant cognition
  • Major psychiatric disorders (DSM-IV-TR) or diseases that could affect cognitive abilities: major depression, bipolar disorder, schizophrenia and dementia.
Show all 9Show fewer
  • Neurological disorders: Parkinson's disease, stroke, epilepsy and treatment with frequent seizures (> 1/month) in the past year, multiple sclerosis or other serious neurological disease.
  • Brain injury interfering with cognition: history of head trauma with parenchymal lesion or extraaxial macroscopic large vessel ischemic stroke or hemorrhagic stroke, brain surgery, brain tumors and other causes that can generate acquired brain damage (cerebral chemotherapy or radiotherapy)
  • Family history of Alzheimer's disease with autosomal dominant (3 affected in two different generations) and early onset age (<60 years).

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • BarcelonaBeta Brain Research Center

    Barcelona, 08005

Other trials in Spain

About this study

Official title: Cross-sectional Study for Cognitive and Genetic Characterization of a 45-65 Years Old Population

Before Alzheimer's disease (AD) clinical symptoms appear, there is a long period when changes in the brain occur. In this long asymptomatic period or preclinical phase, studies with populations at risk of developing AD have shown cognitive differences compared to control groups without such risk. There is a need for short, sensitive, easily administered, reproducible, non-expensive and independent of socio-demographic influences tests enabling the detection of pre-symptomatic variations in memory, when the memory decline is still within a normal range.

Study main hypothesis: When evaluated with high-demanding tests of memory and executive function, the cognitive performance of cognitive healthy people aged between 45 and 65 and, extensively, to a group of up to 75 years, will vary significantly depending on clinical, socio-demographic and genetic features

Read the detailed description

The purpose of Study 45-65 is to assess if:

  • Endogenous factors (clinical history, risk factors, genetic factors APOE4, etc…), exogenous (socio-demographic, ambient and lifestyle variables) and cognitive reserve (including bilingualism) influence cognitive performance.
  • New and/or updated tests translated and validated in Spanish and Catalan when needed, will provide accurate and sensitive measurements of the variability of cognitive performance in this target population, representative of the preclinical phase of Alzheimer's disease.

An optional visit is offered to study participants that includes: cerebral magnetic resonance, vascular ultrasound and olfactory testing.

Keywords
Preclinical phase of Alzheimer's disease, Asymptomatic phase of Alzheimer's disease, Cognitive normal, Exogenous factors, Endogenous factors, Episodic memory test, Executive function test, Memory binding test validation into Spanish, Memory binding test validation into Catalan

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01835717
Study groupRoleWhat they receive
Cognitively normal individualsNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Factors influencing the cognitive performance through demanding tests of episodic memory and executive function

    The following tests will be administered:

    Verbal episodic memory: MBT (Memory Binding Test)

    WAIS-IV subsets: 1 Perceptual reasoning (Visual Puzzles) 2 Logical reasoning (Matrix Reasoning) 3 Executive attention and working memory (Digit span) 4 Speed of processing (Coding) 5 Abstract verbal reasoning (Similarities)

    Factors to be considered:

    Hypertension, diabetes mellitus, and metabolic syndrome APOE4 Cognitive reserve (including bilingualism) Pollution, exposure to toxics, diet

    Measured: single Visit (up to 3 hours)

  2. Culturally adapted validation in Spanish and Catalan of the MBT and determination of normative data for the population under study.

    Measured: single visit (up to 3 hours)

Secondary outcomes (5)

  1. Assessment of the equivalence of the in person and over the phone administration to the close relative of the Clinical Dementia Rating (CDR).

    Measured: single visit/telephone conversation (up to 10 min)

  2. Genetic features of the population

    APOE genotyping is being performed

    Measured: 8 months after study start

  3. Identification of genetic determinants of neuroimaging phenotypes associated to Alzheimer's disease.

    Brain MR (magnetic resonance) as well as GWAS (genome-wide association studies) are being performed

    Measured: 5 years and 8 months after study start

  4. Assessment of the relationship between olfactory and cognitive performance

    Olfaction is assessed with the Burghart Medical Technology (Wedel, Germany) kit containing 16 sniffing sticks

    Measured: 5 years and 8 months after study start

  5. Analysis of the relationship between subclinical atherosclerosis and brain changes, cognitive performance and APOE genotype

    Vascular ultrasound of femoral and carotid arteries will be performed

    Measured: 6 years and 8 months after study start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2013 (estimated)
  2. Study startApr 2013
  3. Primary completion30 Aug 2019
  4. Study completion31 Dec 2020

Resources

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
Cross-sectional
Enrolment
2,743 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01835717
Sponsor's protocol ID
Study 45-65/FPM 2012
Status last verified
Jun 2021
First submitted
15 Apr 2013
Last updated
10 Jun 2021
Results posted
No
Data monitoring committee
No

Publications

  • Munoz-Garcia MI, Deming Y, Lugo-Hernandez F, Johnson S, Asthana S, Kollmorgen G, Quijano-Rubio C, Carlsson C, Okonkwo OC, Perez-Martinez D, Villarejo-Galende A, Blennow K, Suarez-Calvet M, Zetterberg H, Bendlin BB, Morenas-Rodriguez E. Synaptic dysfunction and glial activation markers throughout aging and early neurodegeneration: a longitudinal CSF biomarker-based study. Mol Neurodegener. 2025 Oct 17;20(1):109. doi: 10.1186/s13024-025-00901-5.

    PubMed 41102691

  • Cumplido-Mayoral I, Garcia-Prat M, Operto G, Falcon C, Shekari M, Cacciaglia R, Mila-Aloma M, Lorenzini L, Ingala S, Meije Wink A, Mutsaerts HJMM, Minguillon C, Fauria K, Molinuevo JL, Haller S, Chetelat G, Waldman A, Schwarz AJ, Barkhof F, Suridjan I, Kollmorgen G, Bayfield A, Zetterberg H, Blennow K, Suarez-Calvet M, Vilaplana V, Gispert JD; ALFA study; EPAD study; ADNI study; OASIS study. Biological brain age prediction using machine learning on structural neuroimaging data: Multi-cohort validation against biomarkers of Alzheimer's disease and neurodegeneration stratified by sex. Elife. 2023 Apr 17;12:e81067. doi: 10.7554/eLife.81067.

    PubMed 37067031

  • Ciampa I, Operto G, Falcon C, Minguillon C, Castro de Moura M, Pineyro D, Esteller M, Molinuevo JL, Guigo R, Navarro A, Gispert JD, Vilor-Tejedor N, For The Alfa Study. Genetic Predisposition to Alzheimer's Disease Is Associated with Enlargement of Perivascular Spaces in Centrum Semiovale Region. Genes (Basel). 2021 May 27;12(6):825. doi: 10.3390/genes12060825.

    PubMed 34072165

  • Sala-Vila A, Arenaza-Urquijo EM, Sanchez-Benavides G, Suarez-Calvet M, Mila-Aloma M, Grau-Rivera O, Gonzalez-de-Echavarri JM, Crous-Bou M, Minguillon C, Fauria K, Operto G, Falcon C, Salvado G, Cacciaglia R, Ingala S, Barkhof F, Schroder H, Scarmeas N, Gispert JD, Molinuevo JL; ALFA study. DHA intake relates to better cerebrovascular and neurodegeneration neuroimaging phenotypes in middle-aged adults at increased genetic risk of Alzheimer disease. Am J Clin Nutr. 2021 Jun 1;113(6):1627-1635. doi: 10.1093/ajcn/nqab016.

    PubMed 33733657

  • 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.

    PubMed 33597012

  • Vilor-Tejedor N, Operto G, Evans TE, Falcon C, Crous-Bou M, Minguillon C, Cacciaglia R, Mila-Aloma M, Grau-Rivera O, Suarez-Calvet M, Garrido-Martin D, Moran S, Esteller M, Adams HH, Molinuevo JL, Guigo R, Gispert JD; ALFA Study. Effect of BDNF Val66Met on hippocampal subfields volumes and compensatory interaction with APOE-epsilon4 in middle-age cognitively unimpaired individuals from the ALFA study. Brain Struct Funct. 2020 Nov;225(8):2331-2345. doi: 10.1007/s00429-020-02125-3. Epub 2020 Aug 17.

    PubMed 32804326

  • Ingala S, Mazzai L, Sudre CH, Salvado G, Brugulat-Serrat A, Wottschel V, Falcon C, Operto G, Tijms B, Gispert JD, Molinuevo JL, Barkhof F; ALFA Study. The relation between APOE genotype and cerebral microbleeds in cognitively unimpaired middle- and old-aged individuals. Neurobiol Aging. 2020 Nov;95:104-114. doi: 10.1016/j.neurobiolaging.2020.06.015. Epub 2020 Jun 29.

    PubMed 32791423

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy Individuals, 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 8 inclusion and 9 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: finished, as of the sponsor's last update on 10 Jun 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Factors influencing the cognitive performance through demanding tests of episodic memory and executive function (time frame: single Visit (up to 3 hours)). The study lists 2 primary outcomes in all. 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 NCT01835717, which also lists 7 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 10 Jun 2021; AzTrials last refreshed its copy on 6 Nov 2026.

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