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25 recruiting in MD
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Global Blood-Brain Barrier Disruption and Post-Stroke Cognitive Decline

Ischemic Stroke

The goal of this study is to gain a better understanding of why some individuals who have suffered a stroke experience post-stroke cognitive decline. Specifically this study is testing whether global disruption of the blood-brain barrier detected at the time of the stroke is informative about the risk of post-stroke cognitive decline over the next 3 years.

Baltimore, MD18+ 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, MD50โ€“80 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 ยท 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, MD55โ€“90 yrsAll genders
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PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease

Parkinson's Disease ยท Dementia ยท Alzheimer's Disease

Background: About 5 million adults in the U.S. have Alzheimer s disease or another adult-onset neurodegenerative disorder. Many studies have found that inflammation in the brain contributes to these diseases. Researchers want to find a better way to measure this inflammation. Objective: To learn whether COX-1 and/or COX-2 is elevated in the brains of individuals with neurodegenerative brain disease compared to healthy volunteers. Eligibility: Adults age 18 years and older in good general health who have an adult-onset neurodegenerative dementia, such as AD, FTD, corticobasal syndrome, Huntington s disease, or MCI, ALS and healthy adult volunteers enrolled in protocols 01-M-0254 or 17-M-0181. Design: Participants will be screened with medical history, physical exam with vital signs, and lab tests. They will have a neuropsychological testing. Their heart function will be measured. Participants will have a magnetic resonance imaging (MRI) scan. The MRI scanner is a metal tube surrounded by a strong magnetic field. Participants will lie on a table that slides in and out of the tube. The machine makes noise. Participants will get earplugs. Participants will have 2 PET scans. They will be injected with the study drugs through an intravenous catheter placed in an arm vein. The PET scanner is shaped like a doughnut. Participants will lie on a bed that slides in and out of the scanner. A plastic mask will be molded to their head to keep them from moving. A thin plastic tube will be put into an artery at the wrist or elbow crease area. This will be used to draw blood during the scan. Participants will have 2-5 study visits. Participation lasts 1 week to 4 months, depending on scheduling.

Bethesda, MD18โ€“99 yrsAll genders
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CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms

Traumatic Brain Injury ยท Insomnia ยท 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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Cognitive Vulnerability to Stress in Individuals at Risk for Alzheimer's Disease

Mild Cognitive Impairment ยท 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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Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease

Depressive Symptoms ยท Depression ยท 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, MD18โ€“85 yrsAll genders
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Acoramidis Transthyretin Amyloidosis Prevention Trial in the Young (ACT-EARLY) Study in Asymptomatic Carriers of a Pathogenic TTR Variant

Amyloidosis ยท Amyloid Cardiomyopathy ยท Transthyretin Amyloidosis

Transthyretin amyloidosis (ATTR) is a disease where the normally occurring transthyretin (TTR) protein falls apart and forms amyloid, a sticky plaque-like substance that accumulates in different organs in the body and can cause damage to the organ. There are two ways that the TTR protein can fall apart. One way occurs as a person ages, where the normal TTR protein can fall apart and form amyloid that may no longer be sufficiently cleared by the body. This type of ATTR is known as wild-type ATTR (ATTRwt). The other way occurs when a person inherits a defective TTR gene that causes the TTR protein to spontaneously fall apart. This form of the disease is known as variant ATTR (ATTRv) and can be detected in adults by a genetic test of their TTR gene before they age. Amyloid build-up in the heart causes the heart wall to become thick and stiff and can result in heart failure and even death. Accumulation of TTR amyloid in the heart is known as transthyretin amyloid cardiomyopathy or ATTR-CM. Amyloid can also deposit in the nerve tissues leading to nerve problems. Accumulation of TTR in the nerves is known as transthyretin amyloid polyneuropathy or ATTR-PN. Acoramidis is an experimental drug designed to bind tightly to TTR in the blood and stabilize its structure, so it does not form the harmful amyloid plaques that can cause damage to organs. This study is intended to determine if treatment with acoramidis in participants with ATTRv who have not yet developed any symptoms of disease can prevent or delay the development of ATTR-CM or ATTR-PN disease. If adults with an inherited defective TTR gene are treated early before any of the symptoms of disease have developed, it may be possible to delay the onset or prevent the disease entirely.

Baltimore, MD18โ€“75 yrsAll genders
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Crownlands Observing Progression With Neurons Study

Alzheimer s Disease ยท 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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Medicare Anti-Aฮฒ mAb Coverage With Evidence Development (CED) Study

Mild Alzheimer's Disease ยท Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease

The Anti-Aฮฒ mAb CED Study is a prospective, longitudinal coverage with evidence development (CED) study using clinical data, patient assessments, and administrative claims data of the Medicare population, conducted in accordance to the National Coverage Determination (NCD) on Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease (AD).

Baltimore, MDAll agesAll genders
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Vestibular Therapy in Alzheimer's Disease

Vestibular Diseases ยท Vestibular Disorder ยท 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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Longitudinal Early-onset Alzheimer's Disease Study Protocol

Early Onset Alzheimer Disease ยท Alzheimer Disease ยท Mild Cognitive Impairment

The Longitudinal Early-onset Alzheimer's Disease Study (LEADS) is a non-randomized, natural history, non-treatment study designed to look at disease progression in individuals with early onset cognitive impairment. Clinical, cognitive, imaging, biomarker, and genetic characteristics will be assessed across three cohorts: (1) early onset Alzheimer's Disease (EOAD) participants, (2) early onset non-Alzheimer's Disease (EOnonAD) participants, and (3) cognitively normal (CN) control participants.

Baltimore, MD40โ€“64 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, MD55โ€“110 yrsAll genders
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Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease

Alzheimer Disease ยท 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, MD55โ€“80 yrsAll genders
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