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Attention Training for Learning Enhancement and Resilience Trial (ALERT)

Primary Purpose

Age-related Cognitive Decline

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized Plasticity-Based Adaptive Cognitive Training
Commercially available computerized training
Sponsored by
Posit Science Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-related Cognitive Decline focused on measuring healthy, aging, cognition, age-related cognitive decline

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants must be 65 years of age or older
  • Participants must have a diagnosis of age-related cognitive decline as confirmed by interview and performance on screening assessments
  • Participants must be fluent English speakers
  • Participants must have adequate visual, auditory, and motor capacity to use computerized intervention

Exclusion Criteria:

  • Participants with diagnosis of PTSD, depression or other psychologically diagnosable emotional disorder
  • Participants with a history of conditions that could affect thinking abilities, including brain injury, mental illness, cancer, or other neurological conditions (multiple sclerosis, seizure disorder), HIV/AIDS will be excluded
  • Participants enrolled in another concurrent research study will be excluded
  • Participants who have difficulty performing assessments or comprehending or following spoken instructions, in the judgment of the screening clinician, will be excluded
  • Participants with a current or significant past history of substance abuse will be excluded
  • Participants who show signs of suicidal ideations or behaviors will be excluded and referred for appropriate treatment

Sites / Locations

  • University of Iowa
  • Harvard Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Treatment

Active Comparator

Arm Description

Computerized plasticity-based adaptive cognitive training requiring a total maximum of 36 treatment sessions, 4-5 times weekly, one hour each session.

Commercially available computerized training requiring a total maximum of 36 treatment sessions, 4-5 times weekly, one hour each session.

Outcomes

Primary Outcome Measures

Attention Measures aimed to test attention
Measures aimed to test attention
Executive Function
Tasks targeting inhibitory control
Functional Capacity
Performance on directly observable functional measure

Secondary Outcome Measures

Quality of Sleep
assessing sleep quality

Full Information

First Posted
April 7, 2015
Last Updated
January 7, 2018
Sponsor
Posit Science Corporation
Collaborators
University of Iowa, Harvard Medical School (HMS and HSDM)
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1. Study Identification

Unique Protocol Identification Number
NCT02416401
Brief Title
Attention Training for Learning Enhancement and Resilience Trial
Acronym
ALERT
Official Title
Attention Training for Learning Enhancement and Resilience Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Posit Science Corporation
Collaborators
University of Iowa, Harvard Medical School (HMS and HSDM)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Healthy aging is associated with a decline in multiple cognitive domains, as well as motor control function. The long-term consequences of cognitive and functional impairment resulting from age-related cognitive decline are well documented in the scientific and clinical literature, with significant evidence of related problems with independent functional abilities. This study aims to understand how the experimental computer program can affect cognition and attention in participants with age-related cognitive decline.
Detailed Description
Following consent, participants will engage in an assessment process to determine eligibility. Once eligibility is confirmed, participants will be scheduled for another assessment session to determine current level of cognitive function. This process consists of paper-pencil surveys and computerized tests. Following the assessment process, participants will engage in an Internet browser-delivered training sessions conducted on any internet-accessible computer. The computerized training sessions can be done up to 7 times a week (once a day) or at the participant's convenience (the recommended time commitment is 5 times a week). Following the completion of training, the participant's cognitive function will be re-assessed. Participation is voluntary and participants may withdraw from the study at any time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Cognitive Decline
Keywords
healthy, aging, cognition, age-related cognitive decline

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Treatment
Arm Type
Experimental
Arm Description
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 36 treatment sessions, 4-5 times weekly, one hour each session.
Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
Commercially available computerized training requiring a total maximum of 36 treatment sessions, 4-5 times weekly, one hour each session.
Intervention Type
Other
Intervention Name(s)
Computerized Plasticity-Based Adaptive Cognitive Training
Intervention Type
Other
Intervention Name(s)
Commercially available computerized training
Primary Outcome Measure Information:
Title
Attention Measures aimed to test attention
Description
Measures aimed to test attention
Time Frame
6 months
Title
Executive Function
Description
Tasks targeting inhibitory control
Time Frame
6 months
Title
Functional Capacity
Description
Performance on directly observable functional measure
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Quality of Sleep
Description
assessing sleep quality
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Quality of life
Description
Assessments and questionnaire assessing quality of life
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must be 65 years of age or older Participants must have a diagnosis of age-related cognitive decline as confirmed by interview and performance on screening assessments Participants must be fluent English speakers Participants must have adequate visual, auditory, and motor capacity to use computerized intervention Exclusion Criteria: Participants with diagnosis of PTSD, depression or other psychologically diagnosable emotional disorder Participants with a history of conditions that could affect thinking abilities, including brain injury, mental illness, cancer, or other neurological conditions (multiple sclerosis, seizure disorder), HIV/AIDS will be excluded Participants enrolled in another concurrent research study will be excluded Participants who have difficulty performing assessments or comprehending or following spoken instructions, in the judgment of the screening clinician, will be excluded Participants with a current or significant past history of substance abuse will be excluded Participants who show signs of suicidal ideations or behaviors will be excluded and referred for appropriate treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Van Vleet, PhD
Organizational Affiliation
Posit Science Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Harvard Medical School
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16158065
Citation
Gazzaley A, Cooney JW, Rissman J, D'Esposito M. Top-down suppression deficit underlies working memory impairment in normal aging. Nat Neurosci. 2005 Oct;8(10):1298-300. doi: 10.1038/nn1543. Epub 2005 Sep 11. Erratum In: Nat Neurosci. 2005 Dec;8(12):1791.
Results Reference
background
PubMed Identifier
16888038
Citation
Mahncke HW, Connor BB, Appelman J, Ahsanuddin ON, Hardy JL, Wood RA, Joyce NM, Boniske T, Atkins SM, Merzenich MM. Memory enhancement in healthy older adults using a brain plasticity-based training program: a randomized, controlled study. Proc Natl Acad Sci U S A. 2006 Aug 15;103(33):12523-8. doi: 10.1073/pnas.0605194103. Epub 2006 Aug 3.
Results Reference
background
PubMed Identifier
16371948
Citation
Burke SN, Barnes CA. Neural plasticity in the ageing brain. Nat Rev Neurosci. 2006 Jan;7(1):30-40. doi: 10.1038/nrn1809.
Results Reference
background
PubMed Identifier
16084827
Citation
Cicerone KD, Dahlberg C, Malec JF, Langenbahn DM, Felicetti T, Kneipp S, Ellmo W, Kalmar K, Giacino JT, Harley JP, Laatsch L, Morse PA, Catanese J. Evidence-based cognitive rehabilitation: updated review of the literature from 1998 through 2002. Arch Phys Med Rehabil. 2005 Aug;86(8):1681-92. doi: 10.1016/j.apmr.2005.03.024.
Results Reference
background
PubMed Identifier
29724228
Citation
VanVleet T, Voss M, Dabit S, Mitko A, DeGutis J. Randomized control trial of computer-based training targeting alertness in older adults: the ALERT trial protocol. BMC Psychol. 2018 May 3;6(1):22. doi: 10.1186/s40359-018-0233-4.
Results Reference
derived

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Attention Training for Learning Enhancement and Resilience Trial

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