A Study To Evaluate The Difference In iPad-Based Cognitive Video Game (Akili Interactive's Project: EVO) Performance In Amyloid-Positive Versus Amyloid-Negative Healthy Elderly Volunteers
A Randomized, Double Blind, Placebo Controlled Trial To Study Difference In Cognitive Learning Associated With Repeated Self-administration Of Remote Computer Tablet-based Application Assessing Dual-task Performance Based On Amyloid Status In Healthy Elderly Volunteers
1 other identifier
observational
97
1 country
4
Brief Summary
The purpose of the study is to evaluate the difference in learning and performance measures associated with repeated use of an iPad video game (Akili Interactive's Project: EVO) in healthy elderly volunteers based on amyloid status.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2014
4 active sites
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
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 13, 2014
CompletedFirst Posted
Study publicly available on registry
October 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedJune 5, 2019
June 1, 2019
1.7 years
October 13, 2014
June 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
divided attention performance
The difference in effect of cognitive training on divided attention performance as measured by teh pre/post training change in interference cost on EVO dueal task assessment at Day 28.
Day 0 - Day 28
Secondary Outcomes (3)
sustained attention, impulsivity and episodic memory
Day 0 - Day 28
perforamce on EVO dual task assessment, TOVA and RAVLT
Day 0 - Day 28
within subject change on EVO, TOVA and RAVLT
Day 0 - Day 28
Study Arms (2)
(Amyloid Negative)
Amyloid Positive
Interventions
1 - 20 mg tablet taken once on Day 0 and taken once on Day 28
1 - matching tablet taken once on Day 0 and once on Day 28
Eligibility Criteria
You may qualify if:
- Healthy males and females between the ages of 70 and 80.
- Subjects must have BMI of 17.5 to 32 kg/m2 and total body weight \> 110 pounds.
- Acceptable screening MRI and PET scans that pass quality control requirements.
You may not qualify if:
- Co-morbid diagnosis of clinically documented Alzheimer's disease; - Significant cognitive impairment;
- MMSE (mini mental state examination) score \<26
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (4)
Collaborative Neuroscience Network, LLC
Long Beach, California, 90806, United States
Broward Research Group
Hollywood, Florida, 33024, United States
Miami Research Associates
South Miami, Florida, 33143, United States
Jasper Clinic, Inc.
Kalamazoo, Michigan, 49007, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2014
First Posted
October 16, 2014
Study Start
September 1, 2014
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
June 5, 2019
Record last verified: 2019-06