Clinical trial NCT02416401: Attention Training for Learning Enhancement and Resilience Trial
Official title: Attention Training for Learning Enhancement and Resilience Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-related Cognitive Decline
Keywords: healthy
aging
cognition
age-related cognitive decline
Lead sponsor: Posit Science Corporation
Sponsor class: INDUSTRY
Collaborators: name: University of Iowa
name: Harvard Medical School (HMS and HSDM)
First posted: 2015-04-15
Enrollment: 83
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Attention Measures aimed to test attention
timeFrame: 6 months
measure: Executive Function
timeFrame: 6 months
measure: Functional Capacity
timeFrame: 6 month
Secondary outcomes:
measure: Quality of Sleep
timeFrame: 6 months
Other outcomes:
measure: Quality of life
timeFrame: 6 months
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Boston
country: United States
facility: Harvard Medical School
state: Massachusetts
Study officials:
affiliation: Posit Science Corporation
name: Thomas Van Vleet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: Burke SN, Barnes CA. Neural plasticity in the ageing brain. Nat Rev Neurosci. 2006 Jan;7(1):30-40. doi: 10.1038/nrn1809.
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.
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.