Neurocognitive Study for the Aging-a Longitudinal Study With a Greek Cypriot Cohort (NEUROAGE)

• ClinicalTrials.gov Identifier: NCT01481246
• Recruitment Status: Recruiting
• First Posted: November 29, 2011
• Last Update Posted: April 29, 2022
• Sponsor: University of Cyprus
• Information provided by (Responsible Party): Fofi Constantinidou, University of Cyprus

Study Description

Brief Summary:

The Neurocognitive Study for the Aging (NEUROAGE) was initially funded by the Cyprus Innovation Foundation and has received subsequent funding by the European Union Regional Development Fund. The project focuses on the understanding of the effects of age on neurocognitive abilities such as attention, memory, language, categorization, and executive functioning. In addition, specific arms of the project investigate the effects of a theory-driven hierarchical training program, the Categorization Program, to improve cognitive abilities in adults with Mild Cognitive Impairment (MCI) and of a group intervention program focusing on cognitive and psychosocial abilities. Over 1000 adults ages 40 and older have been recruited in the NEUROAGE project thus far. The grant was awarded to the University of Cyprus, with Professor Fofi Constantinidou as the PI.

Condition or disease	Intervention/treatment
Aging; Memory Impairment; Cognitive Decline; Mild Cognitive Disorder	Behavioral: Categorization training; Behavioral: Psychosocial and Psychoeducational Group training

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:

1. 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.
2. 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.
3. Third, the long term effects of cognitive retraining is being assessed.
4. 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 Design

• Study Type: Observational
• Estimated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Neurocognitive Study for the Aging
• Study Start Date: July 2009
• Estimated Primary Completion Date: March 2023
• Estimated Study Completion Date: March 2023

Groups and Cohorts

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: Categorization training; Behavioral intervention consisting of cognitive training exercises to improve categorization performance; Behavioral: Psychosocial and Psychoeducational Group training; 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.

Outcome Measures

Primary Outcome Measures :

1. Neuropsychological Tests [ Time Frame: on going ]
   a variety of cognitive tests as well as psychosocial measures are used in this project

Biospecimen Retention:   Samples With DNA

APOE phenotyping

Eligibility Criteria

• Ages Eligible for Study: 60 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Normal older adults and adults with cognitive decline are recruited in this study

Criteria

Inclusion Criteria:

• healthy with no prior neurological history

Exclusion Criteria:

• prior neurological history or significant psychiatric history

Contacts and Locations

Contacts

Contact: Fofi Constantinidou, Ph.D.; 35722892078; fofic@ucy.ac.cy

Locations

Cyprus

University of Cyprus; Recruiting

Nicosia, Cyprus, 1678

Contact: Fofi Constantinidou, Ph.D. 35722894437 fofic@ucy.ac.cy

Principal Investigator: Fofi Constantinidou, Ph.D.

Sponsors and Collaborators

University of Cyprus

Investigators

• Principal Investigator: Fofi Constantinidou, Ph.D.; University of Cyprus

More Information

Additional Information:

Center for Applied Neuroscience 

• Responsible Party: Fofi Constantinidou, Professor, University of Cyprus
• ClinicalTrials.gov Identifier: NCT01481246
• Other Study ID Numbers: Humanities/Society/0308(ΒΕ)/07; 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 )
• First Posted: November 29, 2011
• Last Update Posted: April 29, 2022
• Last Verified: April 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fofi Constantinidou, University of Cyprus:

neurorehabilitation; cognition; aging; MCI; cognitive decline

Additional relevant MeSH terms:

Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders