Clinical trial NCT03900702: Training to Enhance Cognition in Older Adults
Official title: Training Foundational Skills to Enhance Cognition in Older Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Enhancement
Aging
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-04-03
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: UFOV Attention Distraction
timeFrame: 12 weeks
measure: UFOV Speed of Processing
timeFrame: 12 weeks
Secondary outcomes:
measure: Repeatable Battery for Neuropsychological Status (RBANS)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Research on Autism and Development Lab, UCSD
state: California
Study officials:
affiliation: UCSD
name: Jeanne Townsend, PhD
role: PRINCIPAL_INVESTIGATOR
References: