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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Ritalin
* Drug: Placebo
* Drug: Ritalin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| (Amyloid Negative)<br> | Drug: Ritalin<br>* 1 - 20 mg tablet taken once on Day 0 and taken once on Day 28<br>* Other names: methylphenidate hydrochloride 20mg tablet taken once on day 0 and once on day 28;Drug: Placebo<br>* 1 - matching tablet taken once on Day 0 and once on Day 28<br>* Other names: matched placebo tablet taken once on day 0 and once on day 28;|
| Amyloid Positive<br> | Drug: Ritalin<br>* 1 - 20 mg tablet taken once on Day 0 and taken once on Day 28<br>* Other names: methylphenidate hydrochloride 20mg tablet taken once on day 0 and once on day 28;Drug: Placebo<br>* 1 - matching tablet taken once on Day 0 and once on Day 28<br>* Other names: matched placebo tablet taken once on day 0 and once on day 28;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy, elderly volunteers