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
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|
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.
|Study Type :||Observational|
|Actual Enrollment :||2743 participants|
|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|
|Cognitively normal individuals|
- 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
- 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) ]
- 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) ]
- Genetic features of the population [ Time Frame: 8 months after study start ]APOE genotyping is being performed
- 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
- 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
- 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
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
|BarcelonaBeta Brain Research Center|
|Barcelona, Spain, 08005|
|Principal Investigator:||José Luis Molinuevo, MD, PhD||Barcelonabeta Brain Research Center, Pasqual Maragall Foundation|