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Completed

NCT Number: NCT02265718

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

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.

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Key information

Conditions

Healthy

Age range

70 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Collaborative Neuroscience Network, LLC, Long Beach, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ritalin

Drug

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

Placebo

Drug

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

Primary outcomes

  1. divided attention performance

    Time frame: 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 outcomes

  1. sustained attention, impulsivity and episodic memory

    Time frame: 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

  2. perforamce on EVO dual task assessment, TOVA and RAVLT

    Time frame: 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

  3. within subject change on EVO, TOVA and RAVLT

    Time frame: Day 0 - Day 28

    The within subject change on EVO dual task assessment, TOVA and RAVLT between day -28 and Day 0.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 16, 2014
Registry last updated
Jun 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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