Attention Training for Learning Enhancement and Resilience Trial

NCT ID: NCT02416401

Last Updated: 2018-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Age-related Cognitive Decline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental Treatment

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

Group Type EXPERIMENTAL

Computerized Plasticity-Based Adaptive Cognitive Training

Intervention Type OTHER

Active Comparator

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

Group Type ACTIVE_COMPARATOR

Commercially available computerized training

Intervention Type OTHER

Interventions

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Computerized Plasticity-Based Adaptive Cognitive Training

Intervention Type OTHER

Commercially available computerized training

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Iowa

OTHER

Sponsor Role collaborator

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role collaborator

Posit Science Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Van Vleet, PhD

Role: PRINCIPAL_INVESTIGATOR

Posit Science Corporation

Locations

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University of Iowa

Iowa City, Iowa, United States

Site Status

Harvard Medical School

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16158065 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16888038 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 16371948 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16084827 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29724228 (View on PubMed)

Other Identifiers

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PSC-1006-14

Identifier Type: -

Identifier Source: org_study_id

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