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

NCT ID: NCT02265718

Last Updated: 2019-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-05-31

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.

Detailed Description

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Conditions

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Healthy

Study Groups

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(Amyloid Negative)

Ritalin

Intervention Type DRUG

1 - 20 mg tablet taken once on Day 0 and taken once on Day 28

Placebo

Intervention Type DRUG

1 - matching tablet taken once on Day 0 and once on Day 28

Amyloid Positive

Ritalin

Intervention Type DRUG

1 - 20 mg tablet taken once on Day 0 and taken once on Day 28

Placebo

Intervention Type DRUG

1 - matching tablet taken once on Day 0 and once on Day 28

Interventions

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Ritalin

1 - 20 mg tablet taken once on Day 0 and taken once on Day 28

Intervention Type DRUG

Placebo

1 - matching tablet taken once on Day 0 and once on Day 28

Intervention Type DRUG

Ritalin

1 - 20 mg tablet taken once on Day 0 and taken once on Day 28

Intervention Type DRUG

Placebo

1 - matching tablet taken once on Day 0 and once on Day 28

Intervention Type DRUG

Other Intervention Names

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methylphenidate hydrochloride 20mg tablet taken once on day 0 and once on day 28 matched placebo tablet taken once on day 0 and once on day 28 methylphenidate hydrochloride 20mg tablet taken once on day 0 and once on day 28 matched placebo tablet taken once on day 0 and once on day 28

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
Minimum Eligible Age

70 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Collaborative Neuroscience Network, LLC

Long Beach, California, United States

Site Status

Broward Research Group

Hollywood, Florida, United States

Site Status

Miami Research Associates

South Miami, Florida, United States

Site Status

Jasper Clinic, Inc.

Kalamazoo, Michigan, United States

Site Status

Countries

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United States

Related Links

Other Identifiers

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A9001489

Identifier Type: -

Identifier Source: org_study_id

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