Plasticity-based Adaptive Cognitive Remediation for Alzheimer Disease

NCT02331784 | Completed DMC

• 1 other identifier: PSC-PACR-AD-01
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Older Adults, Aging Brain

Outcome Measures

Primary Outcomes (1)

• Changes in performance on global cognitive composite score

  Change in performance on global cognitive composite score based on the average of all normalized assessment measures.

  Baseline and at the completion of 10 weeks of training

Secondary Outcomes (6)

• Changes in brain function

  Baseline and at the completion of 10 weeks of training

• Changes in brain structure

  Baseline and at the completion of 10 weeks of training

• Changes in task-related brain activation

  Baseline and at the completion of 10 weeks of training

• Changes in performance on memory composite score

  Baseline and at the completion of 10 weeks of training

• Changes in performance on executive function composite score

  Baseline and at the completion of 10 weeks of training

Other Outcomes (9)

• Changes in Life Satisfaction

  Baseline and at the completion of 10 weeks of training

• Changes in Perceived Stress

  Baseline and at the completion of 10 weeks of training

• Changes in Self-Efficacy

  Baseline and at the completion of 10 weeks of training

Study Arms (2)

Computerized Plasticity-based Software

EXPERIMENTAL

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

Behavioral: Computerized Plasticity-based Software

Commercially available video game

ACTIVE COMPARATOR

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..

Behavioral: Commercially available Video Game

Interventions

Computerized Plasticity-based Software 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).

Computerized Plasticity-based Software

Commercially available Video Game 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).

Commercially available video game

Eligibility Criteria

• Age: 65 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65-79 years at the time of consent
• Fluent English speakers, to ensure reasonable results neuropsychological assessments
• 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
• No evidence of dementia as indicated by Montreal Cognitive Assessment (MoCA) scores \>25

You may not qualify if:

• Diagnosis with Alzheimer's disease or related dementias
• Requiring caregiver assistance in dressing/personal hygiene
• Medical conditions predisposing to imminent functional decline
• Recent participation of computer-delivered cognitive training
• 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.
• Uncorrectable acuity greater than 20/40
• Self-reported cardiovascular disease
• Claustrophobia or any other contraindication to MRI scanning
• Inability to complete a 1-hour MRI
• 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)
• History of brain surgery; removal of brain tissue; or history of stroke.

Sponsors & Collaborators

• Posit Science Corporation: lead
• University of Iowa: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Study Officials

• Hyunkyu Lee, Ph.D.

  Posit Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: January 6, 2015
• Study Start: April 1, 2015
• Primary Completion: April 20, 2017
• Study Completion: April 20, 2017
• Last Updated: April 19, 2019

Record last verified: 2019-04

Locations

US (1)