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| ID | Type | Description | Link |
|---|---|---|---|
| 1115904 | Other Identifier | Central Arkansas Veterans Healthcare System |
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| Name | Class |
|---|---|
| Central Arkansas Veterans Healthcare System | FED |
| University of Arkansas | OTHER |
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Apathy, a profound loss of initiative and motivation, is often seen in older Veterans with memory problems. Apathy leads to serious health problems, increases dependency, and caregiver burden. If untreated, apathy hastens the progression to frank dementia. In a pilot study, the investigators found that apathy, working memory, and function can be restored using magnetic stimulation in some but not all older Veterans. The reason for this variation is unknown. The investigators propose a three-phase study in 125 older Veterans with mild memory problems. Their motivation, memory, and function will be measured periodically. Veterans with apathy that are eligible for treatment will receive either real or sham magnetic stimulation to the front part of their brain over 20 sessions. Genetic testing and biomarkers will be used to differentiate those who respond to magnetic stimulation from those who do not. Impact on function, quality of life, and rates of progression to dementia will also be studied.
A project modification was obtained to conduct a cross-sectional study, the COVID Dementia study. The cross-sectional study will examine the effect of the pandemic on MCI and AD patients and their caregivers ("individual COVID-related factors" such as, personally infected, death of a friend/family member, economic hardship, disruption in care, isolation), barriers to telehealth, caregiver distress, NPS, cognition (including onset of delirium), and function. Our goal is to develop a multi-pronged, remotely deliverable intervention to address consequences of healthcare disruptions in older Veterans with cognitive impairment.
Aim 1. To explore the association between COVID-related factors and neuropsychiatric symptoms in individuals with MCI and AD. Hypothesis: The number of COVID-related factors endorsed by caregivers will be positively correlated with the severity of NPI-Q in individuals with MCI and AD.
Aim 2. To assess cognition (telephonic version of the Montreal Cognitive Assessment; tMoCA12, and daily function (Functional Activities Questionnaire; FAQ13). Hypothesis: The number of COVID-related factors will be positively correlated with the severity of cognitive and functional deficits in individuals with MCI and AD.
Aim 3. To explore the associations among COVID-related factors and caregiver distress. Hypothesis: Caregiver resilience and perceived social support will modify the association between COVID-related factors and severity of distress in caregivers.
Apathy, a profound loss of initiative and motivation, is often seen in older Veterans with memory problems. Apathy leads to serious health problems, increases dependency, and caregiver burden. If untreated, apathy hastens the progression to frank dementia. In a pilot study, the investigators found that apathy, working memory, and function can be restored using magnetic stimulation in some but not all older Veterans. The reason for this variation is unknown. The investigators propose a three-phase study in 125 older Veterans with mild cognitive impairment. Their motivation, other behavioral problems, memory, and function will be measured periodically. Veterans with apathy that are eligible for treatment will receive either real or sham magnetic stimulation to the dorsolateral prefrontal cortex over 20 daily sessions on consecutive week days. Genetic testing and biomarkers will be used to differentiate those who respond to magnetic stimulation from those who do not. Impact on function, quality of life, and rates of progression to dementia will also be studied.
A project modification was obtained to conduct a cross-sectional study, the COVID Dementia study. The cross-sectional study will examine the effect of the pandemic on MCI and AD patients and their caregivers ("individual COVID-related factors" such as, personally infected, death of a friend/family member, economic hardship, disruption in care, isolation), barriers to telehealth, caregiver distress, NPS, cognition (including onset of delirium), and function. Our goal is to develop a multi-pronged, remotely deliverable intervention to address consequences of healthcare disruptions in older Veterans with cognitive impairment.
Aim 1. To explore the association between COVID-related factors and neuropsychiatric symptoms in individuals with MCI and AD. Hypothesis: The number of COVID-related factors endorsed by caregivers will be positively correlated with the severity of NPI-Q in individuals with MCI and AD.
Aim 2. To assess cognition (telephonic version of the Montreal Cognitive Assessment; tMoCA12, and daily function (Functional Activities Questionnaire; FAQ13). Hypothesis: The number of COVID-related factors will be positively correlated with the severity of cognitive and functional deficits in individuals with MCI and AD.
Aim 3. To explore the associations among COVID-related factors and caregiver distress. Hypothesis: Caregiver resilience and perceived social support will modify the association between COVID-related factors and severity of distress in caregivers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apathy +, rTMS - | No Intervention | This arm will be followed without intervention | |
| rTMS | Active Comparator | This group will be randomized to receive rTMS treatment |
|
| Sham | Sham Comparator | This group will be randomized to receive sham treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation | Device | rTMS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Apathy Evaluation Scale Score | Range 18-72 Lower score is improvement | 2 weeks, 6 weeks, 6 months, 12 months, 24 months, 36 months, and 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Modified Mini Mental State Examination Score | Range 0-100 Higher score is improvement | 2 weeks, 6 weeks, 6 months, 12 months, 24 months, 36 months, and 48 months |
| Change in Conner's Continuous Performance Test Commission Error percentage |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropsychiatric Inventory - Questionnaire | To study the impact of COVID pandemic on neuropsychiatric symptoms of dementia. This outcome measure has questions pertaining to twelve neuropsychiatric symptoms seen in dementia. An aggregate score of the symptoms, caregiver distress and change during the COVID pandemic will be reported. Presence or lack of each domain is reported for this study. No range in score for this scale. |
Inclusion Criteria:
Exclusion Criteria:
PHASE I
EXCLUSIONARY DUE TO rTMS: ALL PHASE II AND SUBSET OF PHASE I THAT RECEIVE SINGLE SESSION rTMS
EXCLUSIONARY DUE TO CONFOUNDING WITH APATHY: PHASE II
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| Name | Affiliation | Role |
|---|---|---|
| Prasad R. Padala, MBBS MBBS | Central Arkansas Veterans Healthcare System , Little Rock, AR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Arkansas Veterans Healthcare System , Little Rock, AR | Little Rock | Arkansas | 72205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33511946 | Background | Sharma T, Padala PR, Mehta JL. Loneliness and Social Isolation: Determinants of Cardiovascular Outcomes. Curr Cardiol Rev. 2021;17(6):e051121190873. doi: 10.2174/1573403X17666210129101845. | |
| 33511321 | Background | Padala KP, Jendro AM, Wilson KB, Padala PR. Technology Use to Bridge the Gap of Social Distancing during COVID-19. J Geriatr Med Gerontol. 2020 Jun 29;6(2):10.23937/2469-5858/1510092. doi: 10.23937/2469-5858/1510092. No abstract available. |
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| ID | Term |
|---|---|
| D053609 | Lethargy |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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Range 0-100% Higher score is improvement
| 2 weeks, 6 weeks, 6 months, 12 months, 24 months, 36 months, and 48 months |
| Through study completion, an average of 1 year |
| Functional Activities Questionnaire | Measure of functional independence Range: 0-30 Higher score indicates higher dependence | Through study completion, an average of 1 year |
| UCLA Loneliness scale | Measures loneliness Range 3-9 Higher score indicates higher loneliness | Through study completion, an average of 1 year |
| T-MoCA | Measures global cognition Range: 0-22 Higher scores indicate better cognition | Through study completion, an average of 1 year |
| 32969235 | Background | Padala KP, Parkes CM, Padala PR. Neuropsychological and Functional Impact of COVID-19 on Mild Cognitive Impairment. Am J Alzheimers Dis Other Demen. 2020 Jan-Dec;35:1533317520960875. doi: 10.1177/1533317520960875. |
| 32925060 | Background | Padala PR, Boozer EM, Lensing SY, Parkes CM, Hunter CR, Dennis RA, Caceda R, Padala KP. Neuromodulation for Apathy in Alzheimer's Disease: A Double-Blind, Randomized, Sham-Controlled Pilot Study. J Alzheimers Dis. 2020;77(4):1483-1493. doi: 10.3233/JAD-200640. |
| 34099086 | Background | Preston AM, Padala PR. Virtual reality on the verge of becoming a reality for geriatric research. Int Psychogeriatr. 2022 Feb;34(2):97-99. doi: 10.1017/S1041610221000867. Epub 2021 Jun 8. No abstract available. |
| 34570180 | Background | Mintzer J, Lanctot KL, Scherer RW, Rosenberg PB, Herrmann N, van Dyck CH, Padala PR, Brawman-Mintzer O, Porsteinsson AP, Lerner AJ, Craft S, Levey AI, Burke W, Perin J, Shade D; ADMET 2 Research Group. Effect of Methylphenidate on Apathy in Patients With Alzheimer Disease: The ADMET 2 Randomized Clinical Trial. JAMA Neurol. 2021 Nov 1;78(11):1324-1332. doi: 10.1001/jamaneurol.2021.3356. |
| 34315645 | Background | Mortby ME, Adler L, Aguera-Ortiz L, Bateman DR, Brodaty H, Cantillon M, Geda YE, Ismail Z, Lanctot KL, Marshall GA, Padala PR, Politis A, Rosenberg PB, Siarkos K, Sultzer DL, Theleritis C; ISTAART NPS PIA. Apathy as a Treatment Target in Alzheimer's Disease: Implications for Clinical Trials. Am J Geriatr Psychiatry. 2022 Feb;30(2):119-147. doi: 10.1016/j.jagp.2021.06.016. Epub 2021 Jul 1. |
| 35530116 | Background | Okolichany R, Padala PR, Mooney S. Cognitive and Functional Abilities in an Older Adult Veteran Before and After Contracting COVID-19. J Alzheimers Dis Rep. 2022 Mar 25;6(1):115-120. doi: 10.3233/ADR-210055. eCollection 2022. |
| 36053568 | Background | Preston AM, Brown L, Padala KP, Padala PR. Veterans Affairs Health Care Provider Perceptions of Virtual Reality: Brief Exploratory Survey. Interact J Med Res. 2022 Sep 2;11(2):e38490. doi: 10.2196/38490. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |