Status:
COMPLETED
Study for Cognitive and Genetic Characterization of a 45-65 Years Old Population
Lead Sponsor:
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Collaborating Sponsors:
Obra Social La Caixa, Spain
Conditions:
Healthy Individuals
Eligibility:
All Genders
45-75 years
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 ris...
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 cogn...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- 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).
Key Trial Info
Start Date :
April 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
2743 Patients enrolled
Trial Details
Trial ID
NCT01835717
Start Date
April 1 2013
End Date
December 31 2020
Last Update
June 10 2021
Active Locations (1)
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1
BarcelonaBeta Brain Research Center
Barcelona, Spain, 08005