- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01481246
Neurocognitive Study for the Aging-a Longitudinal Study With a Greek Cypriot Cohort (NEUROAGE)
The Neurocognitive Study for the Aging
Study Overview
Status
Intervention / Treatment
Detailed Description
Given the fact that older adults are expected to live longer while maintaining their social and professional activities, the development of effective cognitive retraining methodologies designed to maximize independence has been of interest. In addition to changes caused by the normal aging process, older adults over 65 are at a high risk for developing dementia. About 8-12% of the older adult population will demonstrate a pre-dementia syndrome referred to as Mild Cognitive Impairment (MCI) which is considered a prodrome to dementia. Consequently, it is important to identify variables that contribute to the development of MCI as well as neurocognitive therapy approaches to help patients improve their level of functioning.
Categorization is one of the most fundamental cognitive processes. The ability to divide the world into discrete categories is a rudimentary process beginning early in life and continues to be developed and refined across the lifespan. This underlying process is crucial to a variety of neurocognitive abilities including attention and memory and can influence vocational and educational reintegration. Normal aging results in categorization deficits which in turn can interfere with the individual's ability to attend, remember, and organize information. This difficulty could hamper activities of daily living, social participation, and independence. This project implements an innovative treatment program based on current theoretical models of human cognition designed to improve neurocognitive abilities.
One of the objectives of the project is to provide evidence on the effectiveness of a systematic and hierarchical neurocognitive therapy method, the Categorization Program (CP) in adults with MCI and in normal older adults. It is hypothesized that the CP will be an effective treatment approach to improve categorization abilities in both groups of subjects. In addition, since 2020, we have been implementing a group intervention program as part of our recent funding to investigate its feasibility in healthy older adults and in adults with MCI.
The following activities have been taking place:
- Initially, a population-based sample of 500 older adults was tested using a battery of neuropsychological measures. Normal older adults are reassessed every two years. Currently, more than 800 healthy adults have been recruited in this project.
- Second, normal OA and adults with MCI have been randomly assigned into either the treated or untreated groups. The treated groups receive the CP training in order to test its effectiveness.
- Third, the long term effects of cognitive retraining is being assessed.
- Finally, the project examines the relationship between the categorization tasks, neuropsychological performance, functional outcome measures, and subject characteristics including health indices, education, and biomarkers. Theoretical constructs such as Cognitive Reserve have been explored as part of this project.
The long-term objective of this research program is to determine variables that influence cognitive decline in older adults and develop effective neurocognitive therapy techniques.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Fofi Constantinidou, Ph.D.
- Phone Number: 35722892078
- Email: fofic@ucy.ac.cy
Study Locations
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Nicosia, Cyprus, 1678
- Recruiting
- University of Cyprus
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Contact:
- Fofi Constantinidou, Ph.D.
- Phone Number: 35722894437
- Email: fofic@ucy.ac.cy
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Principal Investigator:
- Fofi Constantinidou, Ph.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- healthy with no prior neurological history
Exclusion Criteria:
- prior neurological history or significant psychiatric history
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Normal Aging/Cognitive Decline
Health adults as well as adults with MCI and early stage AD are being recruited in the study
|
Behavioral intervention consisting of cognitive training exercises to improve categorization performance
Group treatment with a focus on psychosocial and psychoeducational intervention in healthy adults and in adults with cognitive decline.
Ten week cycle, 2 hours per week group intervention study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neuropsychological Tests
Time Frame: on going
|
a variety of cognitive tests as well as psychosocial measures are used in this project
|
on going
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fofi Constantinidou, Ph.D., University of Cyprus
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Humanities/Society/0308(ΒΕ)/07 (Other Grant/Funding Number: Cyprus Research Promotion Foundation)
- SKEPSH (Other Grant/Funding Number: European Regional Development Fund)
- EXCELLENCE/1216/0404 (Other Grant/Funding Number: Cyprus Research Innovation Foundation)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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