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

Healthy Individuals Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01835717
• Other study ID #: Study 45-65/FPM 2012
• Status: Completed
• Start date: April 2013
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2021
• Source: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2743
• Est. completion date: December 31, 2020
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy Individuals

Locations

Country	Name	City	State
Spain	BarcelonaBeta Brain Research Center	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation	Obra Social La Caixa, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	single Visit (up to 3 hours)
Primary	Culturally adapted validation in Spanish and Catalan of the MBT and determination of normative data for the population under study.		single visit (up to 3 hours)
Secondary	Assessment of the equivalence of the in person and over the phone administration to the close relative of the Clinical Dementia Rating (CDR).		single visit/telephone conversation (up to 10 min)
Secondary	Genetic features of the population	APOE genotyping is being performed	8 months after study start
Secondary	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	5 years and 8 months after study start
Secondary	Assessment of the relationship between olfactory and cognitive performance	Olfaction is assessed with the Burghart Medical Technology (Wedel, Germany) kit containing 16 sniffing sticks	5 years and 8 months after study start
Secondary	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	6 years and 8 months after study start