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CompletedNCT01835717Updated Jun 10, 2021

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

An observational study in Healthy Individuals, sponsored by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation. Completed at 1 site in Spain. Open to participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-10.

Sponsored by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
2,743
Ages
45 Years to 75 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Healthy Individuals

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
03

In context

Lead sponsor

Barcelonabeta Brain Research Center, Pasqual Maragall Foundation is the lead sponsor of 22 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Cognitive normal men and woman aged 45-75 years

Inclusion criteria

  1. Men and women, aged between 45 and 75 years
  2. Spanish and/or Catalan speakers

  3. Agreement with the study procedures and tests:

    1. Clinical Interview and questionnaires associated to risk factors
    2. Cognitive tests
    3. Blood sample extraction for DNA analysis
  4. Close relative involvement for functional evaluation of the volunteer
  5. Signature of informed consent

Exclusion criteria

Exclusion Criteria:

  1. Cognitive impairment: MMSE \<26, o MIS \<6, or orientation subtest of the Barcelona Test II \<68, o category fluency (animals) \<12
  2. Functional status impairment: CDR > 0
  3. Severe auditory and/or visual impairment
  4. Neurodevelopmental and/or psychomotor disorder
  5. 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
  6. Major psychiatric disorders (DSM-IV-TR) or diseases that could affect cognitive abilities: major depression, bipolar disorder, schizophrenia and dementia.
  7. 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.
  8. 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)
  9. Family history of Alzheimer's disease with autosomal dominant (3 affected in two different generations) and early onset age (\<60 years).
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
2,743 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Cognitively normal individuals
06

What researchers measure

Primary outcomes

  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

    Time frame: 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.

    Time frame: single visit (up to 3 hours)

Secondary outcomes

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

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

  2. Genetic features of the population

    APOE genotyping is being performed

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 6 years and 8 months after study start

07

Study locations

1 site
  • BarcelonaBeta Brain Research Center
    Barcelona, 08005, Spain
08

References and documents

Publications

  • 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01835717
Lead sponsor
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Collaborators
Obra Social La Caixa, Spain
Responsible party
Sponsor
First posted
Apr 19, 2013
Start date
Apr 2013
Primary completion
Aug 30, 2019
Completion
Dec 31, 2020
Last update
Jun 10, 2021

Study contacts

José Luis Molinuevo, MD, PhD
principal investigator · Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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