Attention Training for Learning Enhancement and Resilience Trial

NCT02416401 | Completed DMC

• 1 other identifier: PSC-1006-14
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 2

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.

Conditions

Age-related Cognitive Decline

Keywords

healthy; aging; cognition; age-related cognitive decline

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Quality of Sleep

  6 months

Other Outcomes (1)

• Quality of life

  6 months

Study Arms (2)

Experimental Treatment

EXPERIMENTAL

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

Interventions

Computerized Plasticity-Based Adaptive Cognitive Training OTHER

Experimental Treatment

Commercially available computerized training OTHER

Active Comparator

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Posit Science Corporation: lead
• University of Iowa: collaborator
• Harvard Medical School (HMS and HSDM): collaborator

Study Sites (2)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Harvard Medical School

Boston, Massachusetts, 02130, United States

Location

Related Publications (5)

• 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.

  PMID: 16158065 BACKGROUND

• 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.

  PMID: 16888038 BACKGROUND

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

  PMID: 16371948 BACKGROUND

• 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.

  PMID: 16084827 BACKGROUND

• 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.

  PMID: 29724228 DERIVED

Study Officials

• Thomas Van Vleet, PhD

  Posit Science Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: April 15, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 9, 2018

Record last verified: 2018-01

Locations

US (2)