Back to resultsA 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
Primary Purpose
Healthy
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Ritalin
Placebo
Ritalin
Placebo
Sponsored by
About this trial
This is an observational trial for Healthy focused on measuring Healthy, elderly volunteers
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Co-morbid diagnosis of clinically documented Alzheimer's disease; - Significant cognitive impairment;
- MMSE (mini mental state examination) score <26
Sites / Locations
- Collaborative Neuroscience Network, LLC
- Broward Research Group
- Miami Research Associates
- Jasper Clinic, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Arm Label
(Amyloid Negative)
Amyloid Positive
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
sustained attention, impulsivity and episodic memory
The difference in effect of cognitive training on sustained attention, impulsivity and episodic memory as measured by the pre/post training change in performance at day 28
perforamce on EVO dual task assessment, TOVA and RAVLT
The performance on EVO dual task assessment, Test of Variables of Attention (TOVA and Rey Auditory Verbal Learning Test (RAVLT) as measured by the pre and post training scores at Day 0 and Day 28
within subject change on EVO, TOVA and RAVLT
The within subject change on EVO dual task assessment, TOVA and RAVLT between day -28 and Day 0.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02265718
Brief Title
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
Official Title
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
Study Type
Observational
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Healthy, elderly volunteers
7. Study Design
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
(Amyloid Negative)
Arm Title
Amyloid Positive
Intervention Type
Drug
Intervention Name(s)
Ritalin
Other Intervention Name(s)
methylphenidate hydrochloride 20mg tablet taken once on day 0 and once on day 28
Intervention Description
1 - 20 mg tablet taken once on Day 0 and taken once on Day 28
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
matched placebo tablet taken once on day 0 and once on day 28
Intervention Description
1 - matching tablet taken once on Day 0 and once on Day 28
Intervention Type
Drug
Intervention Name(s)
Ritalin
Other Intervention Name(s)
methylphenidate hydrochloride 20mg tablet taken once on day 0 and once on day 28
Intervention Description
1 - 20 mg tablet taken once on Day 0 and taken once on Day 28
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
matched placebo tablet taken once on day 0 and once on day 28
Intervention Description
1 - matching tablet taken once on Day 0 and once on Day 28
Primary Outcome Measure Information:
Title
divided attention performance
Description
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.
Time Frame
Day 0 - Day 28
Secondary Outcome Measure Information:
Title
sustained attention, impulsivity and episodic memory
Description
The difference in effect of cognitive training on sustained attention, impulsivity and episodic memory as measured by the pre/post training change in performance at day 28
Time Frame
Day 0 - Day 28
Title
perforamce on EVO dual task assessment, TOVA and RAVLT
Description
The performance on EVO dual task assessment, Test of Variables of Attention (TOVA and Rey Auditory Verbal Learning Test (RAVLT) as measured by the pre and post training scores at Day 0 and Day 28
Time Frame
Day 0 - Day 28
Title
within subject change on EVO, TOVA and RAVLT
Description
The within subject change on EVO dual task assessment, TOVA and RAVLT between day -28 and Day 0.
Time Frame
Day 0 - Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Co-morbid diagnosis of clinically documented Alzheimer's disease; - Significant cognitive impairment;
MMSE (mini mental state examination) score <26
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Collaborative Neuroscience Network, LLC
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Broward Research Group
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Miami Research Associates
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Jasper Clinic, Inc.
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9001489&StudyName=A%20Study%20To%20Evaluate%20The%20Difference%20In%20iPad-Based%20Cognitive%20Video%20Game%20%28Akili%20Interactive%27s%20Project%3A%20EVO%29%20Performance%20In%20Amyloid-Posi
Description
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Learn more about this trial
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
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