跳至主要内容
临床试验/NCT03962439
NCT03962439终止不适用

Impact of Challenging Engagement on Cognition in Older Adults: A Clinical Trial

The University of Texas at Dallas2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
50
试验地点
2
主要终点
Mean Change in Episodic Memory Function

研究概览

简要总结

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.

详细描述

All older adults experience some degree of cognitive compromise as they age and approximately 32 percent of adults aged 85 and older suffer from Alzheimer's disease (AD). The Alzheimer's Association estimates that delaying the onset of AD symptoms by only five years would reduce the rate of incidence by 50 percent! The present clinical trial builds on a wealth of observational work and more recent experimental research conducted in the PI's lab, which suggests that an important element of maintaining cognitive vitality for life is sustained engagement in mentally-challenging activities. In a U.S. sample of cognitively normal adults, investigators recently demonstrated that older adults who were randomly assigned to learn digital photography, quilting, or both, in fast-paced, demanding classes for 15 hours per week for three months, showed enhanced episodic memory function-both at the end of the engagement period and, importantly, one year later (Park et al., 2014). The observed memory improvements were in comparison to two active control conditions that were low in new learning: a social engagement group that had fun but did not engage in active learning, and a placebo condition where participants worked on low-effort cognitive tasks that relied on use of previous knowledge. The investigators also found similar facilitation effects when older adults were trained to use many different applications on an iPad. The lab most recently reported that older participants who participated in high-effort engagement conditions showed an increase in neural efficiency, exhibiting a change in neural activity from a pre-intervention pattern characteristic of older adults to a post-intervention pattern typical of young adults. Based on these findings, which included relatively small numbers of subjects, the investigators will conduct a larger clinical trial to determine whether mentally challenging activities facilitate memory in cognitively normal adults via changes of neural structure and function. The investigators propose to conduct a clinical trial study that will (a) evaluate the efficacy of different types of engagement in improving cognitive function in older adults, (b) examine the likelihood that mental effort invested is the underlying mechanism accounting for engagement effects, (c) show whether engaging in high-demand activities results in reliable brain changes. The investigators expect to demonstrate that when older adults engage for a sustained period of time in high-effort tasks (learning photography), both their memory and the modulation capacity of their brain will increase.

Randomization Procedure and Statistical Analyses:

Potential participants will complete an initial eligibility form. The investigators will contact those who are deemed eligible, will follow up with a TICS cognitive phone interview screening, and provide the link to an on-line demographic enrollment questionnaire.

The investigators will invite subjects who pass these screens to attend an informational session. At these sessions, project RAs will consent potential participants and have them complete the MRI screening form. The investigators will schedule consenting participants for cognitive testing and MRI scans (if applicable).

During the 3-week period set aside for cognitive and MRI testing, subjects will be assigned among the three treatment arms using a centrally created randomization scheme. Because baseline data for all potential participants will be available at the time of randomization, the rerandomization method of Morgan and Rubin (2012 Annals of Statistics 40:1263) will be utilized, which can achieve improved covariate balance in this setting. The investigators will generate a series of randomizations and evaluate them for balance on age, education, and sex, designating balance in terms of the MANOVA F statistic comparing the distributions of the covariates across the treatment groups. Once a randomization that meets this criterion is identified, it will be applied to the eligible participants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.
  • 10th 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.

排除标准

  • 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
  • Extensive experience with digital photography or post processing photo programs

结局指标

主要结局

Mean Change in Episodic Memory Function

时间窗: Baseline and 16 weeks

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).

Mean Change in Neural Modulation Capacity - Primary Brain Outcome Measure

时间窗: Baseline and 16 weeks

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).

次要结局

  • Working Memory(Baseline and 16 weeks)
  • Speed of Processing(Baseline and 16 weeks)
  • Rey Auditory Verbal Learning Test (RAVLT)(Baseline and 16 weeks)
  • Reasoning(Baseline and 16 weeks)
  • Crystallized Intelligence(Baseline and 16 weeks)
  • Large-scale Brain Measures(Baseline and 16 weeks)
  • Radial Diffusivity(Baseline and 16 weeks)
  • Woodcock-Johnson Memory for Names(Baseline and 16 weeks)
  • Axial Diffusivity(Baseline and 16 weeks)
  • Fractional Anisotropy(Baseline and 16 weeks)
  • NIH Picture Sequence Memory Test(Baseline and 16 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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