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
- Registration Number
- NCT02265718
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 97
- 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.
- Co-morbid diagnosis of clinically documented Alzheimer's disease; - Significant cognitive impairment;
- MMSE (mini mental state examination) score <26
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description (Amyloid Negative) Ritalin - (Amyloid Negative) Placebo - Amyloid Positive Ritalin - Amyloid Positive Placebo -
- Primary Outcome Measures
Name Time Method divided attention performance Day 0 - Day 28 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
Name Time Method sustained attention, impulsivity and episodic memory Day 0 - Day 28 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 Day 0 - Day 28 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 Day 0 - Day 28 The within subject change on EVO dual task assessment, TOVA and RAVLT between day -28 and Day 0.
Trial Locations
- Locations (4)
Collaborative Neuroscience Network, LLC
🇺🇸Long Beach, California, United States
Broward Research Group
🇺🇸Hollywood, Florida, United States
Jasper Clinic, Inc.
🇺🇸Kalamazoo, Michigan, United States
Miami Research Associates
🇺🇸South Miami, Florida, United States