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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT02265718

Collaborator

(none)

Enrollment

Locations

Duration (Months)

24.3

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Ritalin Drug: Placebo Drug: Ritalin Drug: Placebo

Study Design

Study Type:

Observational

Actual Enrollment :

97 participants

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 Start Date :

Sep 1, 2014

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Collaborative Neuroscience Network, LLC	Long Beach	California	United States	90806
2	Broward Research Group	Hollywood	Florida	United States	33024
3	Miami Research Associates	South Miami	Florida	United States	33143
4	Jasper Clinic, Inc.	Kalamazoo	Michigan	United States	49007