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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02265718
Enrollment
97
Registered
2014-10-16
Start date
2014-09-30
Completion date
2016-05-31
Last updated
2019-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy, elderly volunteers

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.

Interventions

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

DRUGPlacebo

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

Sponsors

Pfizer
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
70 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
divided attention performanceDay 0 - Day 28The 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

MeasureTime frameDescription
sustained attention, impulsivity and episodic memoryDay 0 - Day 28The 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 RAVLTDay 0 - Day 28The 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 RAVLTDay 0 - Day 28The within subject change on EVO dual task assessment, TOVA and RAVLT between day -28 and Day 0.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026