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

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ClinicalTrials.gov Identifier: NCT01835717
Recruitment Status : Active, not recruiting
First Posted : April 19, 2013
Last Update Posted : July 21, 2020
Sponsor:
Collaborator:
Obra Social La Caixa, Spain
Information provided by (Responsible Party):
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Brief 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


Condition or disease
Healthy Individuals

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.

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Study Type : Observational
Actual Enrollment : 2743 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Cross-sectional Study for Cognitive and Genetic Characterization of a 45-65 Years Old Population
Actual Study Start Date : April 2013
Actual Primary Completion Date : August 30, 2019
Estimated Study Completion Date : December 31, 2020


Group/Cohort
Cognitively normal individuals



Primary Outcome Measures :
  1. Factors influencing the cognitive performance through demanding tests of episodic memory and executive function [ Time Frame: single Visit (up to 3 hours) ]

    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


  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 Outcome Measures :
  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 [ Time Frame: 8 months after study start ]
    APOE genotyping is being performed

  3. Identification of genetic determinants of neuroimaging phenotypes associated to Alzheimer's disease. [ Time Frame: 5 years and 8 months after study start ]
    Brain MR (magnetic resonance) as well as GWAS (genome-wide association studies) are being performed

  4. Assessment of the relationship between olfactory and cognitive performance [ Time Frame: 5 years and 8 months after study start ]
    Olfaction is assessed with the Burghart Medical Technology (Wedel, Germany) kit containing 16 sniffing sticks

  5. Analysis of the relationship between subclinical atherosclerosis and brain changes, cognitive performance and APOE genotype [ Time Frame: 6 years and 8 months after study start ]
    Vascular ultrasound of femoral and carotid arteries will be performed


Biospecimen Retention:   Samples With DNA
serum; white cells


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Cognitive normal men and woman aged 45-75 years
Criteria

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:

  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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01835717


Locations
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Spain
BarcelonaBeta Brain Research Center
Barcelona, Spain, 08005
Sponsors and Collaborators
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Obra Social La Caixa, Spain
Investigators
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Principal Investigator: José Luis Molinuevo, MD, PhD Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
ClinicalTrials.gov Identifier: NCT01835717    
Other Study ID Numbers: Study 45-65/FPM 2012
First Posted: April 19, 2013    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
Keywords provided by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation:
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