Attention Training for Learning Enhancement and Resilience Trial (ALERT)

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.

Study Overview

• Status: Completed
• Conditions: Age-related Cognitive Decline
• Intervention / Treatment: Other: Computerized Plasticity-Based Adaptive Cognitive Training; Other: Commercially available computerized training

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.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Massachusetts
    • Boston, Massachusetts, United States, 02130
      • Harvard Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Treatment; Computerized plasticity-based adaptive cognitive training requiring a total maximum of 36 treatment sessions, 4-5 times weekly, one hour each session.	Other: Computerized Plasticity-Based Adaptive Cognitive Training
Active Comparator: Active Comparator; Commercially available computerized training requiring a total maximum of 36 treatment sessions, 4-5 times weekly, one hour each session.	Other: Commercially available computerized training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attention Measures aimed to test attention	Measures aimed to test attention	6 months
Executive Function	Tasks targeting inhibitory control	6 months
Functional Capacity	Performance on directly observable functional measure	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Sleep	assessing sleep quality	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Assessments and questionnaire assessing quality of life	6 months

Collaborators and Investigators

• Sponsor: Posit Science Corporation
• Collaborators: Harvard Medical School (HMS and HSDM); University of Iowa

Publications and helpful links

General Publications

• 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.
• 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.
• Burke SN, Barnes CA. Neural plasticity in the ageing brain. Nat Rev Neurosci. 2006 Jan;7(1):30-40. doi: 10.1038/nrn1809.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: April 7, 2015
• First Submitted That Met QC Criteria: April 14, 2015
• First Posted (Estimate): April 15, 2015

Study Record Updates

• Last Update Posted (Actual): January 9, 2018
• Last Update Submitted That Met QC Criteria: January 7, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: cognition; aging; healthy; age-related cognitive decline
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: PSC-1006-14