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Clinical Trials/NCT02265718
NCT02265718
Completed
Not Applicable

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

Pfizer4 sites in 1 country97 target enrollmentSeptember 2014
ConditionsHealthy
InterventionsRitalinPlacebo

Overview

Phase
Not Applicable
Intervention
Ritalin
Conditions
Healthy
Sponsor
Pfizer
Enrollment
97
Locations
4
Primary Endpoint
divided attention performance
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
May 2016
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Pfizer
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Healthy males and females between the ages of 70 and
  • 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

Arms & Interventions

(Amyloid Negative)

Intervention: Ritalin

(Amyloid Negative)

Intervention: Placebo

Amyloid Positive

Intervention: Ritalin

Amyloid Positive

Intervention: Placebo

Outcomes

Primary Outcomes

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

  • sustained attention, impulsivity and episodic memory(Day 0 - Day 28)
  • perforamce on EVO dual task assessment, TOVA and RAVLT(Day 0 - Day 28)
  • within subject change on EVO, TOVA and RAVLT(Day 0 - Day 28)

Study Sites (4)

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