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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

Last updated on November 14, 2019

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Study Location
Collaborative Neuroscience Network, LLC
Long Beach, California, 90806 United States
Contact
1-800-718-1021
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

NCT02265718
Pfizer
Completed
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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Descriptive Information
Brief TitleA 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 TitleA 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 SummaryThe 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 DescriptionNot Provided
Study TypeObservational
Study DesignNot Provided
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNot Provided
Study PopulationNot Provided
ConditionHealthy
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 StatusCompleted
Actual Enrollment
 (submitted: July 25, 2016)
97
Original Estimated Enrollment
 (submitted: October 13, 2014)
200
Actual Study Completion DateMay 2016
Actual Primary Completion DateMay 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
Ages70 Years to 80 Years   (Older Adult)
Accepts Healthy VolunteersYes
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesUnited States
Removed Location Countries  
 
Administrative Information
NCT NumberNCT02265718
Other Study ID NumbersA9001489
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2019

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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