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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Ritalin; Drug: Placebo

• Study Type: Observational
• Enrollment (Actual): 97

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90806
      • Collaborative Neuroscience Network, LLC
  • Florida
    • Hollywood, Florida, United States, 33024
      • Broward Research Group
    • South Miami, Florida, United States, 33143
      • Miami Research Associates
  • Michigan
    • Kalamazoo, Michigan, United States, 49007
      • Jasper Clinic, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years to 80 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
(Amyloid Negative)	Drug: Ritalin; 1 - 20 mg tablet taken once on Day 0 and taken once on Day 28; Other Names: methylphenidate hydrochloride 20mg tablet taken once on day 0 and once on day 28; Drug: Placebo; 1 - matching tablet taken once on Day 0 and once on Day 28; Other Names: matched placebo tablet taken once on day 0 and once on day 28
Amyloid Positive	Drug: Ritalin; 1 - 20 mg tablet taken once on Day 0 and taken once on Day 28; Other Names: methylphenidate hydrochloride 20mg tablet taken once on day 0 and once on day 28; Drug: Placebo; 1 - matching tablet taken once on Day 0 and once on Day 28; Other Names: matched placebo tablet taken once on day 0 and once on day 28

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 0 - 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	Day 0 - 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.	Day 0 - Day 28

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: October 13, 2014
• First Submitted That Met QC Criteria: October 13, 2014
• First Posted (Estimate): October 16, 2014

Study Record Updates

• Last Update Posted (Actual): June 5, 2019
• Last Update Submitted That Met QC Criteria: June 3, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Healthy; elderly volunteers
• Additional Relevant MeSH Terms: Metabolic Diseases; Proteostasis Deficiencies; Amyloidosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Methylphenidate
• Other Study ID Numbers: A9001489