Attention Training for Learning Enhancement and Resilience Trial

Age-related Cognitive Decline Clinical Trial

— ALERT  

Official title:

Attention Training for Learning Enhancement and Resilience Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02416401
• Other study ID #: PSC-1006-14
• Status: Completed
• Phase: N/A
• First received: April 7, 2015
• Last updated: January 7, 2018
• Start date: November 2015
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: Posit Science Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-related Cognitive Decline
• Cognitive Dysfunction

Intervention

Other:
• Computerized Plasticity-Based Adaptive Cognitive Training

• Commercially available computerized training

Locations

Country	Name	City	State
United States	Harvard Medical School	Boston	Massachusetts
United States	University of Iowa	Iowa City	Iowa

Sponsors (3)

Lead Sponsor	Collaborator
Posit Science Corporation	Harvard Medical School, University of Iowa

Country where clinical trial is conducted

United States, 

References & Publications (4)

Burke SN, Barnes CA. Neural plasticity in the ageing brain. Nat Rev Neurosci. 2006 Jan;7(1):30-40. Review. — View 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. Review. — View 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. Epub 2005 Sep 11. Erratum in: Nat Neurosci. 2005 Dec;8(12):1791. — View 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. Epub 2006 Aug 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life	Assessments and questionnaire assessing quality of life	6 months
Primary	Attention Measures aimed to test attention	Measures aimed to test attention	6 months
Primary	Executive Function	Tasks targeting inhibitory control	6 months
Primary	Functional Capacity	Performance on directly observable functional measure	6 month
Secondary	Quality of Sleep	assessing sleep quality	6 months