Training to Enhance Cognition in Older Adults

• Sponsor: Jeanne Townsend, PhD (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03900702
• Collaborator: National Institute on Aging (NIA) (NIH)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 18.5
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Enhancement; Aging	Behavioral: Gaze-driven training games	N/A

Detailed Description

This is a planning trial to optimize procedures for a larger clinical trial. Participants will be randomized into one of two groups--an active group that has intervention training after initial visit and a wait control group that begins intervention after 12 weeks. All participants will receive in-lab baseline testing including IQ (WASI-II), a medical/psychiatric history questionnaire, a depression screen (Geriatric Depression Scale Short Form) and a pre-training battery that includes selected tests from the NIH toolbox, the Repeatable Battery for Neuropsychological Status (RBANS), a Useful Field of View task (UFOV), a driving simulator task, a dual (motor-cognitive) task, an n-back task with and without distractors(with EEG) and 6 minutes of resting state EEG. Participants will be trained to use the game system and play the game at the pre-training in-lab visit. Participants will be provided with a PC with eye-tracker that has training game software installed. Participants will play intervention training games at home for 8-12 weeks with in-lab assessments (the pre-training battery described above). Participants will be asked to play the training games a minimum of 5 times per week for 30 minutes at a time. Compliance will be monitored daily over a secure internet connection. If a participant has played less than the required time in a given week, a research associate will contact the participant to inquire about potential problems and to encourage the participant to resume or increase training time. The first group of 36 participants will receive post-training assessments at 8 weeks, 12 weeks and 6 months. The second group of 36 participants will have an additional pre-training session with structural and functional imaging and will receive only pre- and post-training assessment.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Training Foundational Skills to Enhance Cognition in Older Adults
• Actual Study Start Date: Feb 15, 2019
• Anticipated Primary Completion Date: May 1, 2020
• Anticipated Study Completion Date: Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Active Intervention Gaze-driven games, played at home on PC with eye-tracker, to train resistance to attention distraction and speed of processing.	Behavioral: Gaze-driven training games; 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.
No Intervention: Wait List Control Wait list then cross over to active intervention.

Outcome Measures

Primary Outcome Measures

1. UFOV Attention Distraction [12 weeks]

   Subtest from Useful Field of View Task

2. UFOV Speed of Processing [12 weeks]

   Subtest from Useful Field of View Task

Secondary Outcome Measures

1. Repeatable Battery for Neuropsychological Status (RBANS) [12 weeks]

   Battery to assess general cognitive function

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. age 60-80 years old

2. not demented

3. living independently; and (4) fluent in English.

Exclusion Criteria:

1. history of dementia, stroke, head injury involving loss of consciousness

2. current psychiatric or neurological disorders other than depression/anxiety

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research on Autism and Development Lab, UCSD	La Jolla	California	United States	92122

Sponsors and Collaborators

• Jeanne Townsend, PhD
• National Institute on Aging (NIA)

Investigators

• Principal Investigator: Jeanne Townsend, PhD, UCSD

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jeanne Townsend, PhD, Professor Emeritus, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT03900702
• Other Study ID Numbers: U01AG062371; U01AG062371
• First Posted: Apr 3, 2019
• Last Update Posted: Apr 3, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 3, 2019