Impact of Challenging Engagement on Cognition in Older Adults

NCT03962439 | Terminated Results

• 2 other identifiers: STU 072018-0481R56AG058253-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The study will enroll 90 participants in the "Impact of Challenging Engagement" study and assign them to one of three groups: high-demand photography, moderate-demand photography, and active placebo. These initial groups will allow us to collect data and address the feasibility of converting the project into a full trial. Participants will participate in one of three different engagement conditions for 15 hours per week, based on successful results from the initial Active Interventions for the Aging Mind (AIM) study - approved by University of Texas Southwestern (UTSW) Institutional Review Board (IRB) #072010-144. In the Impact of Challenging Engagement study, the lab will expand on the results of the AIM study to determine if high-demand activities result in any observable brain changes when compared to moderate demand or placebo activities. Behavioral and neural measures of cognitive change will be assessed, providing considerable insight into mechanisms of change. Participants will be characterized thoroughly in terms of behavioral tests of cognitive function, and a subset of subjects who meet neuroimaging criteria will undergo a functional magnetic resonance imaging (fMRI) procedure.

Conditions

Cognitive Change

Keywords

Aging; Cognition; Alzheimer's Disease; Memory; Engagement; Digital Photography; Older Adults; Neural Function; Neuroimaging; Active Learning

Outcome Measures

Primary Outcomes (2)

• Mean Change in Episodic Memory Function

  Cognitive function will be measured using an episodic memory composite score. This score is composed of three tasks that measure episodic memory: National Institutes of Health (NIH) Picture Sequence Memory Test, Woodcock-Johnson Memory for names, and Rey Auditory Verbal Learning Test. A normalized distribution of the dependent variables from these measures will be created by applying a rank-ordered and standardized Blom transformation to pretest and posttest scores. The transformed standardized scores will then be averaged to create the episodic memory composite score. Cronbach's alpha will be calculated to test the internal reliability of the episodic memory construct. These measurements will be taken at baseline, and then following the intervention at week 16. A greater change score (week 16 - baseline), which is reported here, would indicate improved episodic memory (range: -1.2 to 1.2).

  Baseline and 16 weeks

• Mean Change in Neural Modulation Capacity - Primary Brain Outcome Measure

  Brain activity drawn from four brain regions associated with effortful processing and memory-cingulate, precuneus, intraparietal sulcus, and inferior temporal gyrus-will be measured using fMRI. The primary fMRI task involves making living/nonliving judgments to presented words. Participants view a series of 128 nouns for 2500 ms each and judge whether each noun refers to a living or non-living item with a button press (yes or no). Half the words are living and half non-living. Moreover, half of the items within each category are easy to classify (e.g., LION or RADIO) or hard to classify (e.g., VIRUS or ZOMBIE), based on the categorical ambiguity of the item. This task measures modulation capacity between ambiguous and non-ambiguous words, where high modulation reflects greater neural efficiency and low modulation reflects poorer neural efficiency. These measurements will be taken at baseline, and then following the intervention (16 weeks later).

  Baseline and 16 weeks

Secondary Outcomes (11)

• Speed of Processing

  Baseline and 16 weeks

• Working Memory

  Baseline and 16 weeks

• Reasoning

  Baseline and 16 weeks

• Crystallized Intelligence

  Baseline and 16 weeks

• Large-scale Brain Measures

  Baseline and 16 weeks

Study Arms (3)

High-Demand Photography

EXPERIMENTAL

A structured, high-demand photography course targeting 210 hours of engagement over 16 weeks.

Behavioral: High-Demand Photography

Moderate-Demand Photography

ACTIVE COMPARATOR

A structured, moderate-demand photography course targeting 210 hours of engagement over 16 weeks.

Behavioral: Moderate-Demand Photography

At-Home Engagement Group

PLACEBO COMPARATOR

Participation, alone at home, in tasks that are relatively low in intellectual engagement.

Behavioral: At-Home Engagement

Interventions

High-Demand Photography BEHAVIORAL

The high-demand photography group will receive 2.5 hours of instruction, twice a week, in a structured high-demand digital photography course plus 10 hours per week working on a special project at the research site without any formal instruction.

Also known as: Productive Engagement Group (High)

High-Demand Photography

Moderate-Demand Photography BEHAVIORAL

The moderate-demand photography group will receive 2.5 hours of instruction, twice a week, in a structured moderate-demand digital photography course plus 10 hours per week working on a special project at the research site without any formal instruction.

Also known as: Productive Engagement Group (Moderate)

Moderate-Demand Photography

At-Home Engagement BEHAVIORAL

The placebo control group will engage, alone at home, in tasks that are relatively low in intellectual engagement such as listening to music and radio or completing work-books that rely primarily on activation of knowledge.

Also known as: Placebo Control

At-Home Engagement Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be adults at least 60 years old.
• At least 35 percent of participants will be men, and at least 15 percent will be minorities.
• th grade education or higher is required
• Fluent in English
• Alzheimer's Disease Assessment Scale-Cognitive (ADAS-COG) score of zero (a perfect score).
• A score of 18 or higher on the Barthel Index of Daily Functioning.
• Right-handed for magnetic resonance imaging (MRI) scanning.

You may not qualify if:

• Telephone Interview for Cognitive Status (TICS) lower than 25
• Montreal Cognitive Assessment (MOCA) score lower than 26
• Depression based on Center for Epidemiologic Studies Depression Scale (CESD) screening (a score of 27 or greater)
• Major psychiatric or neurological disorder
• Chemotherapy presently or in past year
• Coronary bypass presently or in past year
• History of major substance abuse
• History of central nervous system disease or brain injury
• Corrected vision poorer than 20/40 on Snellen Eye Chart after correction
• Recreational drug use in past six months
• Conditions which would contra-indicate MRI: Prior surgeries and/or implant of pacemakers, pacemaker wires, artificial heart valve, brain aneurysm surgery, middle ear implant, non-removable hearing aid or jewelry, braces or extensive dental work, cataract surgery or lens implant, implanted mechanical or electrical device, artificial limb or joint; foreign metallic objects in the body such as bullets, ball-bullets or ball bearings (BB's), shrapnel, or metalwork fragments; pregnancy, vertigo, claustrophobia, left handedness, Body Mass Index (BMI) greater than 35, uncontrollable shaking, or inability to lie still for one hour.
• More than minimal experience with photography during the last 12 years
• Work at a structured job/volunteer more than 10 hours per week
• Computer experience that involves more than internet surfing and email
• Use of electronic devices to shop, pay bills, bank, and perform other higher-order functions

Sponsors & Collaborators

• The University of Texas at Dallas: lead
• University of Texas Southwestern Medical Center: collaborator
• Southern Methodist University: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

The engAGE Center: A Community Based Engagement Environment

Irving, Texas, 75039, United States

Location

Related Publications (4)

• Weintraub S, Dikmen SS, Heaton RK, Tulsky DS, Zelazo PD, Bauer PJ, Carlozzi NE, Slotkin J, Blitz D, Wallner-Allen K, Fox NA, Beaumont JL, Mungas D, Nowinski CJ, Richler J, Deocampo JA, Anderson JE, Manly JJ, Borosh B, Havlik R, Conway K, Edwards E, Freund L, King JW, Moy C, Witt E, Gershon RC. Cognition assessment using the NIH Toolbox. Neurology. 2013 Mar 12;80(11 Suppl 3):S54-64. doi: 10.1212/WNL.0b013e3182872ded.

  PMID: 23479546 BACKGROUND

• Chan MY, Haber S, Drew LM, Park DC. Training Older Adults to Use Tablet Computers: Does It Enhance Cognitive Function? Gerontologist. 2016 Jun;56(3):475-84. doi: 10.1093/geront/gnu057. Epub 2014 Jun 13.

  PMID: 24928557 BACKGROUND

• Park DC, Lodi-Smith J, Drew L, Haber S, Hebrank A, Bischof GN, Aamodt W. The impact of sustained engagement on cognitive function in older adults: the Synapse Project. Psychol Sci. 2014 Jan;25(1):103-12. doi: 10.1177/0956797613499592. Epub 2013 Nov 8.

  PMID: 24214244 BACKGROUND

• Chan MY, Park DC, Savalia NK, Petersen SE, Wig GS. Decreased segregation of brain systems across the healthy adult lifespan. Proc Natl Acad Sci U S A. 2014 Nov 18;111(46):E4997-5006. doi: 10.1073/pnas.1415122111. Epub 2014 Nov 3.

  PMID: 25368199 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

As reported above, initial analyses of the effect of the photography training manipulation on episodic memory, speed of processing, and reasoning did not meet our a priori two-tailed p \< .05 threshold for statistical significance (observed p-values \> .2), and so the study was terminated. No additional statistical analyses were performed and because of the time-intensive nature of processing imaging data, data for outcome measures 2 and 7-10 were not processed and could not be reported.

Results Point of Contact

• Title: Joseph Hennessee
• Organization: University of Texas at Dallas

joseph.hennessee@utdallas.edu

408-813-4488

Study Officials

• Denise Park, PhD

  The University of Texas at Dallas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 24, 2019
• Study Start: June 1, 2019
• Primary Completion: February 6, 2020
• Study Completion: February 6, 2020
• Last Updated: June 19, 2025
• Results First Posted: April 25, 2024

Record last verified: 2025-06

Locations

US (1)