Training to Enhance Cognition in Older Adults
Training Foundational Skills to Enhance Cognition in Older Adults
1 other identifier
interventional
60
1 country
1
Brief Summary
This is a planning project with a clinical trial pilot to prepare for a larger fully powered clinical trial. Goals of this pilot project are: to identify and address any modifications of the games required for adaptation to diminished sensory abilities; to optimize training dosage and test timing of retention of effects; and to test and refine the battery of outcome assessments. Primary outcome assessment are tests of attention distraction (subtest from a Useful Field of View Test). This pilot will explore a number of secondary outcome measures including EEG and functional imaging biomarkers of change, measures of general cognitive improvement and measures of function including a driving simulator task.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 15, 2019
CompletedFirst Submitted
Initial submission to the registry
April 1, 2019
CompletedFirst Posted
Study publicly available on registry
April 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedApril 3, 2019
April 1, 2019
1.2 years
April 1, 2019
April 1, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
UFOV Attention Distraction
Subtest from Useful Field of View Task
12 weeks
UFOV Speed of Processing
Subtest from Useful Field of View Task
12 weeks
Secondary Outcomes (1)
Repeatable Battery for Neuropsychological Status (RBANS)
12 weeks
Study Arms (2)
Active Intervention
ACTIVE COMPARATORGaze-driven games, played at home on PC with eye-tracker, to train resistance to attention distraction and speed of processing.
Wait List Control
NO INTERVENTIONWait list then cross over to active intervention.
Interventions
Training games are played on a PC with attached eye-tracker. Games include embedded training principles to improve attentional control including resistance to distraction and inhibitory control.
Eligibility Criteria
You may qualify if:
- age 60-80 years old
- not demented
- living independently; and (4) fluent in English.
You may not qualify if:
- history of dementia, stroke, head injury involving loss of consciousness
- current psychiatric or neurological disorders other than depression/anxiety
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jeanne Townsend, PhDlead
- National Institute on Aging (NIA)collaborator
Study Sites (1)
Research on Autism and Development Lab, UCSD
La Jolla, California, 92122, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Jeanne Townsend, PhD
UCSD
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor Emeritus
Study Record Dates
First Submitted
April 1, 2019
First Posted
April 3, 2019
Study Start
February 15, 2019
Primary Completion
May 1, 2020
Study Completion
September 1, 2020
Last Updated
April 3, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data available 1 year following study completion and for 5 years subsequently.
- Access Criteria
- Access for research or educational purposes, by application specifying use.
Data will be available by request to the PI 1 year following completion of study. Materials generated under the project will be disseminated in accordance with University/Participating institutional and NIH policies. Depending on such policies, materials may be transferred to others under the terms of a material transfer agreement. Access to databases and associated software tools generated under the project will be available for educational, research and non-profit purposes. Such access will be provided using web-based applications, as appropriate.