scholarly journals Recruiting and Screening Older Adults With Alzheimer’s Disease for the FIT-AD Trial

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 459-460
Author(s):  
Fang Yu ◽  
Jean Wyman ◽  
Susan Greimel ◽  
Lin Zhang
Keyword(s):  
Alzheimer’S Disease ◽  
Older Adults ◽  
Alzheimer's Disease ◽  
Sample Size ◽  
Controlled Trial ◽  
Community Outreach ◽  
Hippocampal Volume ◽  
Recruitment Rate ◽  
Community Dwelling ◽  
Screening Process

Abstract Recruiting older adults with Alzheimer’s disease (AD) into clinical trials has been very challenging even for resource-rich trials. This presentation will discuss the recruitment rate, screening ratio, and recruitment yield and costs in the FIT-AD Trial. The FIT-AD Trial was a single-site, pilot randomized controlled trial testing the effects of 6-month aerobic exercise on cognition and hippocampal volume in community-dwelling older adults with mild-to-moderate AD dementia. Ten recruitment strategies and a 4-step screening process were used to ensure a homogenous sample and exercise safety. The target sample size was 90. During the 48-month recruitment period, 396 individuals responded to our recruitment, 301 were reached, and 103 were tentatively qualified at step 4. Of these 103, 67 (69.8%) completed the optional magnetic resonance imaging (MRI) component of the trial and 7 were excluded due to abnormal MRIs. In year 4, our sample size was increased to allow individuals in the screening process a chance to enroll, resulting in a final sample size of 96. Per enrolled participant, the recruitment rate was 2.15, the screen ratio was 2.92, and the recruitment yield was 31.9%. Over 49% of the enrolled participants were yielded through referrals (28.1%) and Alzheimer’s Association events/services (21.9%). The total recruitment cost was $38,246 ($398 per randomized participant). The results indicate that a multi-prong, extensive community outreach-based approach is essential in recruiting older adults with AD dementia into an exercise trial. Referral was the most cost-effective strategy. Two individuals needed to be screened to enroll one participant.

Recruitment and Screening Methods in Alzheimer’s Disease Research: The FIT-AD Trial

2021 ◽  
Author(s):  
Susan Greimel ◽  
Jean F Wyman ◽  
Lin Zhang ◽  
Fang Yu
Keyword(s):  
Alzheimer’S Disease ◽  
Older Adults ◽  
Alzheimer's Disease ◽  
Exercise Intervention ◽  
Community Outreach ◽  
Community Dwelling ◽  
Single Site ◽  
Recruitment Strategy ◽  
Screening Methods ◽  
Screening Process

Abstract Background Recruiting older adults with Alzheimer’s disease (AD) dementia into clinical trials is challenging requiring multiple approaches. We describe recruitment and screening processes and results from the FIT-AD Trial, a single site, pilot randomized controlled trial testing the effects of a 6-month aerobic exercise intervention on cognition and hippocampal volume in community-dwelling older adults with mild-to moderate AD dementia. Methods Ten recruitment strategies and a four-step screening process were used to ensure a homogenous sample and exercise safety. The initial target sample was 90 participants over 48 months which was increased to 96 to allow those in the screening process to enroll if qualified. A tertiary analysis of recruitment and screening rates, recruitment yields and costs, and demographic characteristics of participants was conducted. Results During the 48-month recruiting period, 396 potential participants responded to recruitment efforts, 301 individuals were reached and 103 were tentatively qualified. Of these, 67 (69.8%) participants completed the optional magnetic resonance (MRI) imaging and seven were excluded due to abnormal MRI findings. As a result, we enrolled 96 participants with a 2.92 screen ratio, 2.14 recruitment rate, and 31.9% recruitment yield. Referrals (28.1%) and Alzheimer’s Association events/services (21.9%) yielded over 49% of the enrolled participants. Total recruitment cost was $ 38,246 or $ 398 per randomized participant. Conclusions A multi-prong approach involving extensive community outreach was essential in recruiting older adults with AD dementia into a single-site trial. For every randomized participant, three individuals needed to be screened. Referrals were the most cost-effective recruitment strategy.

scholarly journals Mechanistic Effects of Aerobic Exercise in Alzheimer's Disease: Imaging Findings From the Pilot FIT-AD Trial

2021 ◽  
Vol 13 ◽  
Author(s):  
Fang Yu ◽  
Michelle A. Mathiason ◽  
SeungYong Han ◽  
Jeffrey L. Gunter ◽  
David Jones ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Aerobic Exercise ◽  
Cortical Thickness ◽  
Controlled Trial ◽  
Hippocampal Volume ◽  
Community Dwelling ◽  
White Matter Hyperintensity ◽  
Moderate Intensity ◽  
Intervention Period

Despite strong evidence from animal models of Alzheimer's disease (AD) supporting aerobic exercise as a disease-modifying treatment for AD, human mechanistic studies are limited with mixed findings. The objective of this pilot randomized controlled trial was to examine the effects of 6-month aerobic exercise on hippocampal volume, temporal meta-regions of interest (ROI) cortical thickness, white matter hyperintensity (WMH) volume, and network failure quotient (NFQ), measured with MRI, in community-dwelling older adults with AD dementia. Additionally, the relationships between 6- and 12-month changes in MRI biomarkers and the AD Assessment Scale-Cognition (ADAS-Cog) were examined. Sixty participants were randomized, but one was excluded because baseline MRI failed quality control: 38 randomized to cycling and 21 to stretching. The intervention was moderate-intensity cycling for 20–50 mins, three times a week for 6 months. Control was low-intensity stretching. The study outcomes include hippocampal volume, temporal meta-ROI cortical thickness, WMH volume, and NFQ. Outcomes were measured at baseline, 6 months, and 12 months. The sample averaged 77.3 ± 6.3 years old with 15.6 ± 2.9 years of education and 53% men. Both groups experienced significant declines over 6 months in hippocampal volume (2.64% in cycling vs. 2.89% in stretching) and temporal meta-ROI cortical thickness (0.94 vs. 1.54%), and over 12 months in hippocampal volume (4.47 vs. 3.84%) and temporal meta-ROI cortical thickness (2.27 vs. 1.79%). These declines did not differ between groups. WMH volume increased significantly with the cycling group increasing less (10.9%) than stretching (24.5%) over 6 months (f = 4.47, p = 0.04) and over 12 months (12.1 vs. 27.6%, f = 5.88, p = 0.02). NFQ did not change significantly over time. Pairwise correlational analyses showed a significant negative correlation between 6-month changes in hippocampal volume and ADAS-Cog (r = −0.34, p < 0.05). To conclude, aerobic exercise may reduce the decline in hippocampal volume and temporal meta-ROI cortical thickness during the intervention period, but the effect sizes are likely to be very small and dose-dependent and reverse once the intervention stops. Aerobic exercise is effective on slowing down WMH progression but has no effect on NFQ. Hippocampal atrophy was associated with cognitive decline during the intervention period.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT01954550.

scholarly journals Perceptions of Treatment Burden Among Elders With Diabetes and Comorbid Alzheimer’s Disease and Related Dementias

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 276-276
Author(s):  
Victoria Vaughan Dickson ◽  
Halia Melnyk ◽  
Rosie Ferris ◽  
Joshua Chodosh ◽  
Caroline Blaum
Keyword(s):  
Alzheimer’S Disease ◽  
Older Adults ◽  
Alzheimer's Disease ◽  
Qualitative Study ◽  
Financial Burden ◽  
Controlled Trial ◽  
Healthcare Providers ◽  
Patient Treatment ◽  
Treatment Burden ◽  
Treatment Plans

Abstract Background: An estimated 25% of older adults with diabetes (DM) may have co-occurring Alzheimer’s Disease and Related Dementias (ADRD), complicated by multiple treatment plans and providers. Assessing treatment burden has been limited to patients’ perspectives; little is known about caregiver perceptions of treatment burden despite their important role in personal care and treatment adherence. The purpose of this qualitative study was to describe caregiver perceptions of treatment burden for older adults with DM-ADRD. Methods: This qualitative study was conducted in the formative phase of “Enhanced Quality in Primary care for Elders with DM-ADRD (EQUIPED-ADRD) a pragmatic randomized controlled trial in a large, diverse healthcare system. A diverse sample of caregivers (n=15) of patients enrolled in the RCT participated in interviews about their caregiver role and perceptions of treatment burden of DM-ADRD clinical management. Qualitative data were analyzed using content analysis and themes about treatment burden were compared to domains on the Treatment Burden Questionnaire (TBQ). Results: Caregivers reported high levels of burden related to treatment plans for patients with DM-ADRD. Themes related to complexity and burden of medication management, monitoring (e.g., blood pressure, glucose monitoring), dietary and physical activity regimens, navigating healthcare providers and financial burden were reported. Caregivers also described high levels of emotional burden that was associated with patient’s cognitive decline and family functioning stress. Conclusions: Interventions to reduce treatment burden for patients and caregiver should include activating social/nursing services, respite care and care coordination that may support caregivers especially as patient treatment increases in complexity over time.

scholarly journals Cognitive Effects of Aerobic Exercise in Alzheimer’s Disease: A Pilot Randomized Controlled Trial

2021 ◽  
pp. 1-12
Author(s):  
Fang Yu ◽  
David M. Vock ◽  
Lin Zhang ◽  
Dereck Salisbury ◽  
Nathaniel W. Nelson ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Older Adults ◽  
Alzheimer's Disease ◽  
Randomized Controlled Trial ◽  
Aerobic Exercise ◽  
Controlled Trial ◽  
Moderate Intensity ◽  
Cognitive Effects ◽  
Data Set ◽  
Randomized Controlled

Background: Aerobic exercise has shown inconsistent cognitive effects in older adults with Alzheimer’s disease (AD) dementia. Objective: To examine the immediate and longitudinal effects of 6-month cycling on cognition in older adults with AD dementia. Methods: This randomized controlled trial randomized 96 participants (64 to cycling and 32 to stretching for six months) and followed them for another six months. The intervention was supervised, moderate-intensity cycling for 20–50 minutes, 3 times a week for six months. The control was light-intensity stretching. Cognition was assessed at baseline, 3, 6, 9, and 12 months using the AD Assessment Scale-Cognition (ADAS-Cog). Discrete cognitive domains were measured using the AD Uniform Data Set battery. Results: The participants were 77.4±6.8 years old with 15.6±2.9 years of education, and 55%were male. The 6-month change in ADAS-Cog was 1.0±4.6 (cycling) and 0.1±4.1 (stretching), which were both significantly less than the natural 3.2±6.3-point increase observed naturally with disease progression. The 12-month change was 2.4±5.2 (cycling) and 2.2±5.7 (control). ADAS-Cog did not differ between groups at 6 (p = 0.386) and 12 months (p = 0.856). There were no differences in the 12-month rate of change in ADAS-Cog (0.192 versus 0.197, p = 0.967), memory (–0.012 versus –0.019, p = 0.373), executive function (–0.020 versus –0.012, p = 0.383), attention (–0.035 versus –0.033, p = 0.908), or language (–0.028 versus –0.026, p = 0.756). Conclusion: Exercise may reduce decline in global cognition in older adults with mild-to-moderate AD dementia. Aerobic exercise did not show superior cognitive effects to stretching in our pilot trial, possibly due to the lack of power.

scholarly journals Communicating 5-Year Risk of Alzheimer’s Disease Dementia: Development and Evaluation of Materials that Incorporate Multiple Genetic and Biomarker Research Results

2020 ◽  
pp. 1-14
Author(s):  
Jessica Mozersky ◽  
Sarah Hartz ◽  
Erin Linnenbringer ◽  
Lillie Levin ◽  
Marissa Streitz ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Older Adults ◽  
Alzheimer's Disease ◽  
Absolute Risk ◽  
Brain Mri ◽  
Community Dwelling ◽  
Educational Materials ◽  
Research Results ◽  
Material Development ◽  
Biomarker Research

Background: Cognitively normal (CN) older adults participating in Alzheimer’s disease (AD) research increasingly ask for their research results—including genetic and neuroimaging findings—to understand their risk of developing AD dementia. AD research results are typically not returned for multiple reasons, including possible psychosocial harms of knowing one is at risk of a highly feared and untreatable disease. Objective: We developed materials that convey information about 5-year absolute risk of developing AD dementia based on research results. Methods: 20 CN older adults who received a research brain MRI result were interviewed regarding their wishes for research results to inform material development (Pilot 1). Following material development, 17 CN older adults evaluated the materials for clarity and acceptability (Pilot 2). All participants were community-dwelling older adults participating in longitudinal studies of aging at a single site. Results: Participants want information on their risk of developing AD dementia to better understand their own health, satisfy curiosity, inform family, and future planning. Some articulated concerns, but the majority wanted to know their risk despite the limitations of information. Participants found the educational materials and results report clear and acceptable, and the majority would want to know their research results after reviewing them. Conclusion: These materials will be used in a clinical study examining the psychosocial and cognitive effects of offering research results to a cohort of CN older adults. Future AD research may incorporate the return of complex risk information to CN older adults, and materials are needed to communicate this information.

scholarly journals Methylphenidate for Apathy in Community-Dwelling Older Veterans With Mild Alzheimer’s Disease: A Double-Blind, Randomized, Placebo-Controlled Trial

2018 ◽  
Vol 175 (2) ◽  
pp. 159-168 ◽  
Author(s):  
Prasad R. Padala ◽  
Kalpana P. Padala ◽  
Shelly Y. Lensing ◽  
Daniel Ramirez ◽  
Varun Monga ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Double Blind

scholarly journals Aerobic Fitness and Cognition Changes After Exercise Training in Alzheimer's Disease

2017 ◽  
Vol 6 (2) ◽  
pp. 22-28
Author(s):  
Dereck L. Salisbury ◽  
Fang Yu
Keyword(s):  
Alzheimer’S Disease ◽  
Older Adults ◽  
Alzheimer's Disease ◽  
Linear Regression ◽  
Exercise Training ◽  
Aerobic Fitness ◽  
Repeated Measures ◽  
The United States ◽  
Community Dwelling ◽  
The Relationship

Background: Alzheimer's disease (AD) currently affects 5.4 million Americans and is the sixth leading cause of death in the United States. The mechanism of exercise-induced brain adaptations are not fully understood, but enhanced aerobic fitness has been postulated as an essential physiological mechanism and is beginning to be studied. The purpose of this analysis was to examine the relationship between changes in aerobic fitness and cognition following 6 months of aerobic exercise training in older adults with AD. Methods: Twenty-seven community-dwelling older adults with mild to moderate AD completed a 6-month, 3 times per week, moderate-vigorous intensity cycling exercise program in 2 identical studies using a single-group repeated-measures designs. AD symptoms were measured with the AD Assessment Scale–cognitive subscale (ADAS-cog), while aerobic fitness was assessed by the intermittent shuttle walk test (ISWT) at baseline and 6 months. Pearson's correlation coefficient tests and linear regression were used to assess the relationship between changes in aerobic fitness and cognition. Results: Adjusted for age, the 6-month change in ISWT distance had an inverse relationship with the 6-month change in ADAS-Cog (r = −0.49; P = .01), indicating that enhanced aerobic fitness was associated with improved cognitive changes. Linear regression was statistically significant when adjusted by age (F([2,14] =5.33, P =.01, R2 = .31). Conclusion: Enhanced aerobic fitness may attenuate cognitive decline in persons with mild to moderate AD.

scholarly journals Examining the benefits and harms of Alzheimer’s disease screening for family members of older adults: study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Nicole Fowler ◽  
Katherine J. Head ◽  
Anthony J. Perkins ◽  
Sujuan Gao ◽  
Christopher M. Callahan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Alzheimer’S Disease ◽  
Older Adults ◽  
Alzheimer's Disease ◽  
Randomized Controlled Trial ◽  
Early Detection ◽  
Controlled Trial ◽  
Diagnostic Evaluation ◽  
Randomized Controlled

Abstract Background Multiple national expert panels have identified early detection of Alzheimer’s disease and related dementias (ADRD) as a national priority. However, the United States Preventive Services Task Force (USPSTF) does not currently support screening for ADRD in primary care given that the risks and benefits are unknown. The USPSTF stresses the need for research examining the impact of ADRD screening on family caregiver outcomes. Methods The Caregiver Outcomes of Alzheimer’s Disease Screening (COADS) is a randomized controlled trial that will examine the potential benefits or harms of ADRD screening on family caregivers. It will also compare the effectiveness of two strategies for diagnostic evaluation and management after ADRD screening. COADS will enroll 1,800 dyads, who will be randomized into three groups (n=600/group): Screening Only group will receive ADRD screening at baseline with disclosure of the screening results and a list of local resources for diagnostic follow-up; Screening Plus, ADRD screening at baseline coupled with disclosure of the screening results, with positive screen participants referred to a dementia collaborative care program for diagnostic evaluation and potential care; and Control, no screening. The COADS trial will measure the family member quality of life (primary outcome) and family member mood, anxiety, preparedness, and self-efficacy (secondary outcomes) at baseline, 6, 12, 18 and 24 months. Additionally, the trial will examine the congruence of depressive and anxiety symptoms between older adults and family members at 6, 12, 18 and 24 months and compare the effectiveness of two strategies for diagnostic evaluation and management after ADRD screening between the two groups randomized to screening (Screening Only versus Screening Plus). Discussion We hypothesize that caregivers in the screening arms will express higher levels of health-related quality of life, lower depressive and anxiety symptoms, and better preparation for caregiving with higher self-efficacy at 24 months. Results from this study will directly inform the National Plan to Address Alzheimer’s Disease, the USPSTF and other organizations regarding ADRD screening and early detection policies.

Outcome of a Targeted Nutritional Intervention Among Older Adults With Early-Stage Alzheimer’s Disease: The Nutrition Intervention Study

2016 ◽  
Vol 36 (7) ◽  
pp. 782-807 ◽  
Author(s):  
Bryna Shatenstein ◽  
Marie-Jeanne Kergoat ◽  
Isabelle Reid
Keyword(s):  
Alzheimer’S Disease ◽  
Older Adults ◽  
Alzheimer's Disease ◽  
Intervention Program ◽  
Dietary Intervention ◽  
Early Stage ◽  
Intervention Group ◽  
Community Dwelling ◽  
Nutrition Intervention ◽  
Control Group

A 6-month dietary intervention program was designed for community-dwelling older adults with Alzheimer’s disease. Sixty-seven persons aged 70 years and above were recruited with their caregivers from six hospital memory and geriatric outpatient clinics, and allocated to intervention ( n = 34 dyads) or control group ( n = 33 dyads). Usual diet was assessed by a validated food frequency questionnaire and current diet by two nonconsecutive diet recalls or records corroborated by caregivers, at recruitment (T1) and exit from the study (T2). Intervention participants received targeted dietary recommendations; control participants received Canada’s Food Guide leaflets. The program was assessed using paired and independent t tests and nonparametric statistics. Fat intakes increased at T2 within intervention participants (54 ± 16 vs. 67 ± 23 g, p = .013), and there was a tendency for higher energy, protein, and calcium intakes at T2 within this group. Proportions with adequate protein intakes almost doubled from T1 to T2 in intervention group women ( p = .028) but decreased in female controls ( p = .030). Longer follow-up is necessary to determine persistence of benefits.

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