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34 recruiting in PA
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Improving Access to Care for Veterans With Memory Loss

Alzheimer Disease

This study evaluates a care delivery protocol to improve access to care for Veterans with Alzheimer's Disease and Related Disorders (ADRD). A randomized controlled trial will enroll Veterans with mild cognitive impairment or early dementia at VA Pittsburgh. The ADRD care delivery protocol integrates telehealth, advanced diagnostics, and streamlined workflows to expedite screening for eligibility for amyloid targeting therapies.

Pittsburgh, PA18+ yrsAll genders
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Characterizing Cognitive Decline in Late Life Depression: The ADNI Depression Project

Major Depression ยท Late Life Depression (LLD)

The purpose of this research study is to characterize the mechanisms contributing to cognitive impairment and accelerated cognitive decline in Late Life Depression (LLD). This is a non-randomized, observational, non-treatment study that originally launched in 2015, enrolling 133 participants. From the originally enrolled participants, the continuation of the ADNI-D study will enroll 120 participants which will include following participants from the original (parent) protocol and enrollment of new participants for a period of 30 months. Data from an additional 300 non-depressed subjects will be used from ADNI studies for comparison. Depression history, symptom severity and health information will be collected at the initial visit to determine eligibility. An magnetic resonance imaging (MRI) scan, as well as amyloid (florbetapir) and tau (flortaucipr) positron emission tomography (PET) imaging will be conducted at San Francisco VA. Collection of plasma and serum for biomarkers, clinical assessments and cognitive assessments will be conducted at two time points. Blood samples will also be collected for genetic analysis.

Pittsburgh, PA65+ yrsAll genders
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Tau PET/CT Imaging in the Mismatch Prospective Cohort Study (MPC-TAU)

Alzheimer's Disease

To collect Tau PET/CT imaging in older adults diagnosed with Mild Cognitive Impairment (MCI) or Alzheimer's Disease (AD) in the Mismatch Prospective Cohort Study (MPC-Tau) study to determine relationship to clinical, cognitive, and other biomarker data. Findings from this study will likely provide insight into the phenotypic variability of Alzheimer's Disease and other related pathologies.

Philadelphia, PA18โ€“120 yrsAll genders
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The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study

Obstructive Sleep Apnea ยท Cognitive Decline

The Effects of Successful OSA TreatmENT on Memory and AD BIomarkers in Older AduLts (ESSENTIAL) study is a 5-year, multicenter randomized open-label trial that will screen 400 cognitively normal older adults recruited from well-established sleep clinics at 4 academic medical centers, with newly diagnosed moderate-severe OSA. An expected 200 OSA patients will be then randomized to one of two groups: i) a 3-month OSA treatment by any combination of PAP, OAT, and positional therapy that results in an "effective" AHI4%\< 10/hour and AHI3A\<20/hour (see below); ii) a waitlist control group to receive treatment at the conclusion of the 3-month intervention period. Both groups will continue follow-up for 24 months on stable therapy to determine if sustained improvements in sleep are associated with improvement in cognitive function and AD biomarkers.

Pittsburgh, PA55โ€“85 yrsAll genders
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A Study to Investigate the Safety and Effectiveness of SAR448851 in Participants With Early Alzheimer's Disease

Dementia, Alzheimer's Type ยท Alzheimer's Disease

This is a randomized, placebo-controlled Phase 2 study to evaluate the efficacy and safety of SAR448851 in early Alzheimer's disease (AD) participants. The purpose of this study is to measure efficacy and safety with once daily oral SAR448851 compared to placebo in participants with mild cognitive impairment due to AD or mild AD dementia and with evidence of cerebral amyloid pathology. This Phase 2 study has 2 parts: Part A is a randomized, double-blind, parallel-group, placebo-controlled study with SAR448851 oral once daily. Part B is an open-label extension. All participants who complete Part A may continue to Part B. An optional dose 2 cohort will be considered to evaluate the efficacy and safety of SAR448851 dose 2 oral once daily. The study duration will be up to 111 weeks for Part A and B, and up to 63 weeks for the dose 2 cohort. The treatment duration will be up to 96 weeks for Part A and B, and up to 48 weeks for the dose 2 cohort. Up to 160 participants will be included in this study.

Plymouth Meeting, PA55โ€“85 yrsAll genders
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PET Imaging Tau Accumulation in FTLD and Atypical Alzheimer's Using [18F]-PI-2620

Frontotemporal Lobar Degeneration ยท Alzheimer Disease ยท Cognitively Normal

The investigators will compare \[18F\]-PI-2620 tau PET scans from patients with frontotemporal lobar degeneration (FTLD), patients with non-amnestic presentations of Alzheimer's disease (naAD), and demographically matched cognitively normal subjects.

Philadelphia, PA18+ yrsAll genders
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Safety And Tolerability Of Gamma Glutamylcysteine (GGC) Oral Supplementation In MCI Patients

Mild Cognitive Impairment (MCI)

The goal of this study is to evaluate the safety and tolerability of Gamma Glutamylcysteine (GGC) supplement at different doses (400mg/day or 800mg/day or 1200mg/day) when administered orally to patients with MCI over 3 months. This study is designed to generate preliminary clinical safety data to inform the feasibility and design of larger controlled trials.

Pittsburgh, PA55โ€“80 yrsAll genders
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A Study of a Potential Disease Modifying Treatment in Individuals at Risk for or With a Type of Early Onset AD Caused by a Genetic Mutation

Alzheimers Disease ยท Dementia ยท Alzheimers Disease, Familial

The purpose of this research study is to test the study drug, referred to as remternetug, to determine its effectiveness for the study treatment of asymptomatic (at risk) Alzheimer disease in individuals with AD-causing mutations. This study will also investigate the effects of remternetug on biomarkers (measures of the disease including brain scans, blood and spinal fluid tests), examine safety data to identify any potential benefits or risks, and examine how well participants can tolerate remternetug. Stage 1 will determine if treatment with the study drug prevents or reverses amyloid beta (Aฮฒ) accumulation compared with placebo in participants with dominantly inherited Alzheimer's disease (DIAD). Stage 2 will evaluate the effect of early anti-amyloid treatment on downstream biomarkers of AD in treated participants compared to external control groups.

Pittsburgh, PA18+ yrsAll genders
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Sense4Safety Intervention

Mild Cognitive Impairment

Falls and fall-related injuries are significant public health issues for adults 65 years of age and older. Over a third of older adults (OA) fall each year and 10-20% of falls result in serious injuries such as fractures and head trauma. The annual direct medical costs in the US as a result of falls are estimated to exceed $50 billion, and this estimate does not include the indirect costs of disability, dependence, and decreased quality of life. This project targets community dwelling OA with mild cognitive impairment (MCI). MCI is a leading risk factor for falls in OA. Approximately 15%-20% of OA have MCI, and over 60% of OA with MCI fall annually - two to three times the rate of those without cognitive impairment. We have developed and pilot-tested an innovative technology-supported intervention called Sense4Safety to 1) identify escalating risk for falls real-time through in-home passive sensor monitoring; 2) employ machine learning to inform individualized alerts for fall risk; and 3) link 'at risk' older adults with a coach who will guide them in implementing evidence-based individualized plans to reduce fall-risk. The purpose of this study is to assess the effectiveness of Sense4Safety in reducing fall risk with a randomized clinical trial, and understand implementation factors to improve the scalability of Sense4Safety in diverse community settings.

Philadelphia, PA65+ yrsAll genders
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A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1)

Psychosis Associated With Alzheimer's Disease

This is a Phase 3, 38-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with psychosis associated with Alzheimer's Disease. The primary objective of the study is to evaluate relapse prevention in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo. The secondary objectives of the study are to evaluate the time from randomization to discontinuation for any reason or relapse and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.

Allentown, PA55โ€“90 yrsAll genders
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A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004)

Early Alzheimer's Disease

Researchers want to know if the study treatment called MK-2214 works to slow certain changes in the brains of people with Alzheimer's disease (AD). AD is a type of dementia that can cause loss of memory, communication (such as speech), and decision-making skills. It can limit a person's ability to do daily tasks. MK-2214 is a study treatment designed to slow down AD. The goals of the study are to learn: * If MK-2214 slows the spread of tau in the brain compared to placebo. Tau is a protein that accumulates in AD \& damages brain cells. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of a study treatment. * About the safety of MK-2214 and if people tolerate it

Plymouth Meeting, PA50โ€“85 yrsAll genders
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Determinants of Incident Stroke Cognitive Outcomes and Vascular Effects on RecoverY

Ischemic Stroke ยท Intracerebral Hemorrhage ยท Subarachnoid Hemorrhage

The overall goal of the DISCOVERY study is to better understand what factors contribute to changes in cognitive (i.e., thinking and memory) abilities in patients who experienced a stroke. The purpose of the study is to help doctors identify patients at risk for dementia (decline in memory, thinking and other mental abilities that significantly affects daily functioning) after their stroke so that future treatments may be developed to improve outcomes in stroke patients. For this study, a "stroke" is defined as either (1) an acute ischemic stroke (AIS, or blood clot in the brain), (2) an intracerebral hemorrhage (ICH, or bleeding in the brain), (3) or an aneurysmal subarachnoid hemorrhage (aSAH, or bleeding around the brain caused by an abnormal bulge in a blood vessel that bursts). The investigators hypothesize that: 1. The size, type and location of the stroke play an important role in recovery of thinking and memory abilities after stroke, and pre-existing indicators of brain health further determine the extent of this recovery. 2. Specific stroke events occurring in individuals with underlying genetic or biological risk factors can cause further declines in brain heath, leading to changes in thinking and memory abilities after stroke. 3. Studying thinking and memory alongside brain imaging and blood samples in patients who have had a stroke allows for earlier identification of declining brain health and development of individualized treatment plans to improve patient outcomes in the future.

Philadelphia, PA18+ yrsAll genders
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Using the EHR to Advance Genomic Medicine Across a Diverse Health System

Genetic Predisposition ยท Paraganglioma ยท Pheochromocytoma

Given the expansion of indications for genetic testing and our understanding of conditions for which the results change medical management, it is imperative to consider novel ways to deliver care beyond the traditional genetic counseling visit, which are both amenable to large-scale implementation and sustainable. The investigators propose an entirely new approach for the implementation of genomic medicine, supported by the leadership of Penn Medicine, investigating the use of non-geneticist clinician and patient nudges in the delivery of genomic medicine through a pragmatic randomized clinical trial, addressing NHGRI priorities. Our application is highly conceptually and technically innovative, building upon expertise and infrastructure already in place. Innovative qualities of our proposal include: 1) Cutting edge EHR infrastructure already built to support genomic medicine (e.g., partnering with multiple commercial genetic testing laboratories for direct test ordering and results reporting in the EHR); 2) Automated EHR-based direct ordering or referring by specialist clinicians (i.e., use of replicable modules that enable specialist clinicians to order genetic testing through Epic Smartsets, including all needed components, such as populated gene lists, smartphrases, genetic testing, informational websites and acknowledgement e-forms for patient signature); 3) EHR algorithms for accurate patient identification (i.e., electronic phenotype algorithms to identify eligible patients, none of which currently have phenotype algorithms present in PheKB; 4) Behavioral economics-informed implementation science methods: This trial will be the first to evaluate implementation strategies informed by behavioral economics, directed at clinicians and/or patients, for increasing the use of genetic testing; further it will be the first study in this area to test two forms of defaults as a potential local adaptation to facilitate implementation (ordering vs. referring); and 5) Dissemination: In addition to standard dissemination modalities,PheKB95, GitHub and Epic Community Library, the investigators propose to disseminate via AnVIL (NHGRI's Genomic Data Science Analysis, Visualization, and Informatics Lab-Space). Our results will represent an entirely new paradigm for the provision of genomic medicine for patients in whom the results of genetic testing change medical management.

Philadelphia, PA18+ yrsAll genders
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