Plasticity-based Adaptive Cognitive Remediation for Alzheimer Disease

NCT ID: NCT02331784

Last Updated: 2019-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-04-20

Brief Summary

The primary objective of this study is to evaluate the effects of the experimental treatment (cognitive training) further outlined in this protocol on the cognitive abilities (e.g., processing speed, attention, working memory, and executive function), brain functionality, functional status and quality of life of individuals with age-related cognitive decline as compared to a computer-based active control.

Detailed Description

The normal aging has a devastating effect on our cognitive ability to learn and remember, on the speed with which the investigators process information, and on our ability to reason. By 2050, nearly 14 million individuals in the US will be living with Alzheimer's disease (AD), up from 5 million in 2013. AD is the most common cause of dementia, resulting in the loss of cognitive functions such as memory, reasoning, language, and cognitive, social, physical, and emotional control, to the extent that losses interfere with activities of daily living and necessitate continuous monitoring and care. Many studies now show that the processing machinery of the brain is plastic and remodeled throughout life by learning and experience, enabling the strengthening of cognitive skills or abilities. Research has shown that brief, daily computerized cognitive training that is sufficiently challenging, goal-directed and adaptive enables intact brain structures to restore balance in attention and compensate for disruptions in cognitive functioning. The study aims to understand how our computer program can affect cognition and attention in those with aging brain.

Conditions

Older Adults, Aging Brain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Computerized Plasticity-based Software

Computerized Plasticity-based software training requiring a total maximum of 50 treatment sessions, 4-5 times weekly, 40 minutes each session.

Group Type: EXPERIMENTAL

Computerized Plasticity-based Software

Intervention Type: BEHAVIORAL

Participants will be asked to use their assigned training program for forty minutes per session, up to five sessions per week, over 10 weeks (50 total sessions).

Commercially available video game

Commercially available video game training. Treatment is software based, will occur up to 50 times throughout study duration, 4-5 times per week, 40 minutes each session..

Group Type: ACTIVE_COMPARATOR

Commercially available Video Game

Intervention Type: BEHAVIORAL

Participants will be asked to use their assigned video games for forty minutes per session, up to five sessions per week, over 10 weeks (50 total sessions).

Interventions

Computerized Plasticity-based Software

Participants will be asked to use their assigned training program for forty minutes per session, up to five sessions per week, over 10 weeks (50 total sessions).

Intervention Type: BEHAVIORAL

Commercially available Video Game

Participants will be asked to use their assigned video games for forty minutes per session, up to five sessions per week, over 10 weeks (50 total sessions).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Age 65-79 years at the time of consent

2. Fluent English speakers, to ensure reasonable results neuropsychological assessments

3. Adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse

4. No evidence of dementia as indicated by Montreal Cognitive Assessment (MoCA) scores >25

Exclusion Criteria

1. Diagnosis with Alzheimer's disease or related dementias

2. Requiring caregiver assistance in dressing/personal hygiene

3. Medical conditions predisposing to imminent functional decline

4. Recent participation of computer-delivered cognitive training

5. Diagnosis of an illness or condition with known cognitive consequences (e.g., schizophrenia, bipolar disorder, cancer, multiple sclerosis) will be excluded due to the confound with cognitive impairment from normal aging.

6. Uncorrectable acuity greater than 20/40

7. Self-reported cardiovascular disease

8. Claustrophobia or any other contraindication to MRI scanning

9. Inability to complete a 1-hour MRI

10. Any implanted devices above the waist (e.g., cardiac pacemaker or auto-defibrillators, neural pacemaker, aneurysm clips, cochlear implant, metallic bodies in the eye or central nervous system, any form of wires or metal devices that may concentrate radio frequency fields)

11. History of brain surgery; removal of brain tissue; or history of stroke.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Iowa

OTHER

Sponsor Role: collaborator

Posit Science Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hyunkyu Lee, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Posit Science

Locations

University of Iowa

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

PSC-PACR-AD-01

Identifier Type: -

Identifier Source: org_study_id