Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2026-03-08 @ 1:47 AM
Study NCT ID:
NCT02265718
Status:
COMPLETED
Last Update Posted:
2019-06-05
First Post:
2014-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008774', 'term': 'Methylphenidate'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-03', 'studyFirstSubmitDate': '2014-10-13', 'studyFirstSubmitQcDate': '2014-10-13', 'lastUpdatePostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'divided attention performance', 'timeFrame': 'Day 0 - Day 28', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'sustained attention, impulsivity and episodic memory', 'timeFrame': 'Day 0 - Day 28', 'description': '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'}, {'measure': 'perforamce on EVO dual task assessment, TOVA and RAVLT', 'timeFrame': 'Day 0 - Day 28', 'description': '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'}, {'measure': 'within subject change on EVO, TOVA and RAVLT', 'timeFrame': 'Day 0 - Day 28', 'description': 'The within subject change on EVO dual task assessment, TOVA and RAVLT between day -28 and Day 0.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy', 'elderly volunteers'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9001489&StudyName=A%20Study%20To%20Evaluate%20The%20Difference%20In%20iPad-Based%20Cognitive%20Video%20Game%20%28Akili%20Interactive%27s%20Project%3A%20EVO%29%20Performance%20In%20Amyloid-Posi', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '70 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy males and females between the ages of 70 and 80.\n* Subjects must have BMI of 17.5 to 32 kg/m2 and total body weight \\> 110 pounds.\n* Acceptable screening MRI and PET scans that pass quality control requirements.\n\nExclusion Criteria:\n\n* Co-morbid diagnosis of clinically documented Alzheimer's disease; - Significant cognitive impairment;\n* MMSE (mini mental state examination) score \\<26"}, 'identificationModule': {'nctId': 'NCT02265718', 'briefTitle': "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", 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'A9001489'}}, 'armsInterventionsModule': {'armGroups': [{'label': '(Amyloid Negative)', 'interventionNames': ['Drug: Ritalin', 'Drug: Placebo']}, {'label': 'Amyloid Positive', 'interventionNames': ['Drug: Ritalin', 'Drug: Placebo']}], 'interventions': [{'name': 'Ritalin', 'type': 'DRUG', 'otherNames': ['methylphenidate hydrochloride 20mg tablet taken once on day 0 and once on day 28'], 'description': '1 - 20 mg tablet taken once on Day 0 and taken once on Day 28', 'armGroupLabels': ['(Amyloid Negative)']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['matched placebo tablet taken once on day 0 and once on day 28'], 'description': '1 - matching tablet taken once on Day 0 and once on Day 28', 'armGroupLabels': ['(Amyloid Negative)']}, {'name': 'Ritalin', 'type': 'DRUG', 'otherNames': ['methylphenidate hydrochloride 20mg tablet taken once on day 0 and once on day 28'], 'description': '1 - 20 mg tablet taken once on Day 0 and taken once on Day 28', 'armGroupLabels': ['Amyloid Positive']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['matched placebo tablet taken once on day 0 and once on day 28'], 'description': '1 - matching tablet taken once on Day 0 and once on Day 28', 'armGroupLabels': ['Amyloid Positive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative Neuroscience Network, LLC', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Broward Research Group', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Research Associates', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '49007', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Jasper Clinic, Inc.', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}