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25 recruiting in MD
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CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms

Traumatic Brain Injury · Insomnia · Depression

This study is a prospective two-arm, single blind randomized controlled trial design to compare the clinical effectiveness of telemedicine-delivered, 6-session, standardized cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia symptoms and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid Post-Traumatic Stress Symptoms (PTSS) and insomnia symptoms in a 360 patients. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep monitoring) at baseline, at the end of treatment, and at 2-, 6- and 12-weeks post-treatment. The primary outcome is sleep as measured by the Insomnia Severity Index (ISI).

Bethesda, MD18+ yrsAll genders
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Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease

Depressive Symptoms · Depression · Alzheimer Disease

This open-label pilot study examines whether the hallucinogenic drug, psilocybin, given under supportive conditions, is safe and effective for depression in people with Mild Cognitive Impairment (MCI) or early Alzheimer's Disease (AD). This study will also assess whether psilocybin may improve quality of life in those individuals.

Baltimore, MD18–85 yrsAll genders
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A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)

Alzheimer Disease · Agitation

The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in participants with agitation associated with Alzheimer's Disease who completed the parent studies CN012-0023 or CN012-0024.

Gaithersburg, MD55–90 yrsAll genders
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Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease

Alzheimer Disease · Alzheimer Disease Due to P. Gingivalis

This study is to test LHP588 in persons who have mild to moderate Alzheimer's disease (AD) who have shown progressive mental decline in the last year and who have P. gingivalis (Pg) infection. P. gingivalis infection has been linked to the development of dementia. LHP588 is designed to target the P. gingivalis bacterium, to potentially help to halt or slow down the progression of AD and its symptoms. A saliva test will be done to determine P. gingivalis infection. Tests for AD include standard questionnaires such as MMSE and a blood test for pTau217. Treatment will be blinded, meaning the participant and the doctor will not know if the participant is receiving LHP588 or placebo. The total time for participation in the study may be up to 64 weeks. This includes a screening period (to ensure the participant is suitable for the study and the study is suitable for the participant) of up to 12 weeks, a treatment period of up to 48 weeks, and a safety follow-up period of 4 weeks after the last dose of the study drug to check the participant's overall health. Treatment is a once-a-day capsule. Caregiver participation is required. The study requires the participant to visit the study center (with the caregiver) at least 20 times within 64 weeks (this does not include any unplanned visits that may be recommended by the study doctor). In addition, the study doctor or clinic staff will contact the participant via phone at least 1 time.

Pikesville, MD55–80 yrsAll genders
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PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)

Alzheimer s Disease · Mild Cognitive Impairment · Healthy

Background: About 5 million adults in the United States have age-related brain disorders. These include Alzheimer disease (AD), mild cognitive impairment (MCI), and other dementias. The number of people with these disorders will likely increase as the population ages and life span increases. Inflammation is thought to play a role in AD and MCI. Researchers want to know if an enzyme called PDE4B increases inflammation in people with AD or MCI. Objective: To test whether medical imaging using a new radiotracer (\[18F\]PF-06445974) can measure PDE4B in the brains of people with AD or MCI. Eligibility: People aged 50 years and older with AD or MCI. Healthy volunteers are also needed. Design: Participants will have up to 5 clinic visits with 3 imaging scans of the brain. They will have be screened. They will have a physical exam with blood tests. This will include tests of their heart and nerve function, including memory. Participants will have 2 positron emission tomography (PET) scans. One will use a standard radiotracer. The other will use the study radiotracer. They will receive each tracer through a tube attached to a needle inserted into a vein. During the scan with the study tracer, participants will have a second tube inserted into a vein in the wrist; this tube will be used to draw blood during the scan. Participants will lie on a bed that slides into a doughnut-shaped machine. These visits will take about 6 hours each. Participants will have 1 magnetic resonance imaging (MRI) scan. They will lie on a bed that slides into a cylinder. This visit will take up to 2 hours....

Bethesda, MD50–100 yrsAll genders
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Cognitive Vulnerability to Stress in Individuals at Risk for Alzheimer's Disease

Mild Cognitive Impairment · Alzheimer Disease

The goal of this clinical trial is to learn about how genetics and the response to stress predicts cognitive decline in individuals with mild cognitive impairment. The main question\[s\] it aims to answer are: * Does the hormone response to acute stress predict the degree of cognitive impairment following acute stress? * Do genes associated with the risk for Alzheimer's disease influence the relationship between stress hormone response to stress and cognitive impairment following stress? * Do cognitive impairment following acute stress and genes associated with the risk for Alzheimer's disease predict cognitive decline and change in biomarkers for Alzheimer's disease 2 years later? Participants will have 3 in-person study visits. The first 2 will occur at baseline and the 3rd visit will occur 2 years later. During the visits, participants will provide blood and saliva samples, undergo a 10-minute social stress procedure, complete questionnaires, and take tests of memory and other thinking skills. Someone who knows the participant (a "study partner") will be asked questions about the participant's daily functioning at the first and 3rd study visits.

Baltimore, MD60+ yrsAll genders
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Crownlands Observing Progression With Neurons Study

Alzheimer s Disease · Mild Cognitive Impairment (MCI)

The CROWN-I Study is an observational study to learn about molecular features of Alzheimer's disease (AD) and mild cognitive impairment (MCI). The primary objective is to identify the molecular and genetic modules that differentiate patient subtypes and predict progression of AD. Participants will visit clinical sites to donate samples multiple times and perform virtual and in-person clinical assessments.

Germantown, MD55+ yrsAll genders
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Working Memory and Physical Exercise Training in Patients With Mild Cognitive Impairment

Mild Cognitive Impairment

The prevalence of dementia will double in the next three decades in the U.S.; effective treatment or prevention for dementia is urgently needed. The current exploratory project aims to evaluate and understand how the brain and cognition may improve after a 12-week intervention that combines brain training and aerobic exercise training to improve brain function, both in those with mild cognitive impairment (some with possible prodromal Alzheimer's disease) and with healthy aging. Findings from this pilot project will guide and refine the development of a future larger clinical trial that aligns with the goals of the National Alzheimer's Plan of Action (NAPA), especially regarding "Prevent and Effectively Treat Alzheimer's Disease (AD) by 2025.

Baltimore, MD50–80 yrsAll genders
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Determinants of Incident Stroke Cognitive Outcomes and Vascular Effects on RecoverY

Ischemic Stroke · Intracerebral Hemorrhage · 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.

Baltimore, MD18+ yrsAll genders
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Music Therapy for Patients With Alzheimer's Disease

Mild Cognitive Impairment · Alzheimer Disease

This study is designed to assess the feasibility that individualized reminiscence-based virtual music therapy sessions can enhance autobiographical memory, mood, and cognition in patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's Disease (AD). 60 patients with MCI or mild dementia due to AD will receive two 30 minutes reminiscence-targeted virtual music therapy interventions per week for 8 weeks (a total of 16 sessions). Participants' (or supported by the study partner) self-reported and measurable outcomes including cognitive, anxiety, quality of life, and autobiographical memory will be assessed before and after the 8-week course of treatment. Blood-oxygenation level-dependent (BOLD) in functional magnetic resonance imaging (fMRI) will also be also measured before and after the 8-week course of treatment.

Baltimore, MD18–89 yrsAll genders
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Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging

Aging

Background: Some people experience cognitive decline as they age. That is, they lose memory, problem-solving, and other mental abilities. Amyloids are groups of proteins that develop in the brain and increase in number as people age. Researchers want to use imaging scans to track amyloids in people s brains over time. Their goal is to find out if any changes are related to cognitive decline or other medical issues. Objective: To learn how amyloids may affect brain structure and function as people age. Eligibility: People aged 55 years and older who are enrolled in the Baltimore Longitudinal Study of Aging. Design: Participants will have imaging scans and other tests every 1 to 4 years, depending on their age. Those 80 and older will be scanned yearly. These scans will be done during regular BLSA visits. The scans will be positron emission tomography and computed tomography (PET CT). Participants will be given fluid through a tube inserted into a vein in their arm. The fluid is a tracer that will cause the amyloids to light up in the images. Then they will lie on a bed with their head inside a PET CT scanner. They will lie still for about 30 minutes. Participants will have tests to assess their memory and other mental skills. They will answer questions about their mood and daily life. These tests will take about 40 minutes to complete; they may be done in person or by phone. Participants will give a contact number for someone who can answer questions about the participant s daily routine. These questions may be answered in person or by phone. Participants will be in this study for 5 years.

Baltimore, MD55–110 yrsAll genders
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ACP-204 in Adults With Alzheimer's Disease Psychosis

Alzheimer's Disease Psychosis

This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in patients with ADP * Substudy 1 (Phase 2) will evaluate efficacy and dose response of ACP-204 30 and 60 mg vs placebo. This substudy will be initiated first. * Substudies 2A and 2B (both: Phase 3) will be confirmatory studies of either both doses (ACP-204 30 and 60 mg, respectively) or a single dose from Part 1 vs placebo. Substudies 2A and 2B will be performed independently of each other and will commence after enrollment of Part 1. All 3 substudies will be analyzed independently of each other. Each substudy individually will consist of a screening period (up to 49 days); a double-blind treatment period (6 weeks); a safety follow-up period (30 days) for patients not rolling over into an open-label extension study; and vital status follow-up (for patients who terminated their substudy early).

Gaithersburg, MD55–95 yrsAll genders
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HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms

Alzheimer Disease · Dementia · Hearing Loss

This randomized controlled trial study aims to evaluate a revised hearing care intervention for older adults with Alzheimer's Disease and Related Dementias (ADRD). The community-delivered hearing care intervention utilizes tailored strategies to assess impact on communication, neuropsychiatric symptoms (NPS), and care partner distress.

Baltimore, MD60–100 yrsAll genders
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e-ALIGN: A Patient Portal-based Intervention to Align Medications With What Matters Most

Dementia · Potentially Inappropriate Medication Use · Mild Cognitive Impairment (MCI)

The overarching goal of this study is to pilot an intervention in which older adults with mild cognitive impairment and dementia and the older adult's care partners are identified in primary care and provided with educational materials through the patient portal to engage the participant in deprescribing. The multicomponent intervention, e-Align, includes delivery of educational information through the patient portal, and a pharmacist-led intervention to align medications with patient and care partner goals and reduce use of central nervous system (CNS) potentially inappropriate medicines (PIM). This work will establish the preliminary data, methods, and partnerships to undertake a multisite embedded pragmatic clinical trial. The resulting triadic-based behavioral intervention will promote patient and care partner engagement, and foster care that aligns with patients' values, and promote improved health and well-being outcomes for people with cognitive impairment and the patient's care partners through deprescribing.

Baltimore, MD65+ yrsAll genders
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Vestibular Therapy in Alzheimer's Disease

Vestibular Diseases · Vestibular Disorder · Alzheimer Disease

Nearly 2 out of 3 patients with Alzheimer's disease (AD) experience problems with balance and mobility, which places such patients at increased risk of falling. The vestibular (inner ear balance) system plays an important role in balance stability, and vestibular therapy (VT) is well-known to improve balance function in healthy older adults. In this study, the investigators will conduct a first-in-kind randomized clinical trial to evaluate whether vestibular therapy improves reduces falls in patients with AD, in whom this treatment has never been studied.

Baltimore, MD60+ yrsAll genders
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