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

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NCT02265718

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Study Location
Collaborative Neuroscience Network, LLC
Long Beach, California, 90806, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
70-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Co-morbid diagnosis of clinically documented Alzheimer's disease; - Significant
cognitive impairment;


- MMSE (mini mental state examination) score <26

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Advanced Information
Descriptive Information
Brief Title 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
Official 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Healthy
Intervention
  • Drug: Ritalin
    1 - 20 mg tablet taken once on Day 0 and taken once on Day 28
    Other Name: methylphenidate hydrochloride 20mg tablet taken once on day 0 and once on day 28
  • Drug: Placebo
    1 - matching tablet taken once on Day 0 and once on Day 28
    Other Name: matched placebo tablet taken once on day 0 and once on day 28
Study Groups/Cohorts
  • (Amyloid Negative)
    Interventions:
    • Drug: Ritalin
    • Drug: Placebo
  • Amyloid Positive
    Interventions:
    • Drug: Ritalin
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 25, 2016)		97
Original Estimated Enrollment
 (submitted: October 13, 2014)		200
Actual Study Completion Date May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study:All
Ages 70 Years to 80 Years   (Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02265718
Other Study ID Numbers A9001489
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2019