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Found 5 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating MK-2214, a study treatment designed to slow certain brain changes in people with early Alzheimer's disease (AD), a condition that causes memory loss, speech difficulties, and problems with decision-making. The study aims to find out if MK-2214 can slow the spread of tau protein in the brain compared to a placebo and to assess the treatment's safety and tolerability. Tau is a protein that builds up in AD and damages brain cells, impacting daily functioning. Participants will be randomly assigned to receive either MK-2214 or a placebo through intravenous (IV) infusions every 4 weeks during the study period. The study uses a quadruple-blind design, meaning that participants, care providers, researchers, and those assessing outcomes will not know which treatment is given. This phase 2 trial is planned to last up to approximately 23 months for treatment and assessment. During the study, participants will undergo brain scans including tau PET imaging and assessments of cognitive and daily living abilities at regular intervals. Researchers will monitor changes in tau protein levels, cognitive scores such as the Clinical Dementia Rating-Sum of Boxes (CDR-SB), and safety outcomes including adverse events and treatment discontinuations. The total study duration includes up to about 26 months of follow-up to evaluate safety and effectiveness.

Age: 50Years - 85YearsAll GendersPhase 2
78 locations
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Actively Recruiting

Researchers are evaluating the safety and effectiveness of trontinemab in people aged 50 to 90 years who have early symptomatic Alzheimer's disease, ranging from mild cognitive impairment to mild dementia. The study is a phase III trial designed to compare trontinemab with a placebo to better understand its impact on cognitive decline in Alzheimer's patients. Participants will be randomly assigned to receive either intravenous (IV) trontinemab or an IV placebo. The study is double-blind, meaning neither the participants nor the researchers know who receives the drug or placebo. Treatment and monitoring will continue for 72 weeks, during which various cognitive and biological measures will be assessed. Throughout the study, participants will undergo regular assessments including cognitive tests like the Clinical Dementia Rating, Sum of Boxes (CDR-SB), and the Mini-Mental State Examination (MMSE). Brain imaging scans such as amyloid and tau PET scans, as well as MRI, will be used to observe changes in brain pathology. Researchers will also monitor safety by tracking adverse events, infusion reactions, and the presence of antibodies against trontinemab. Participants will be supported by a study partner and will be closely followed during the entire study period.

Age: 50Years - 90YearsAll GendersPhase 3
150 locations
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Actively Recruiting

Researchers are investigating the efficacy and safety of KarXT combined with KarX-EC for treating cognitive impairment in people with mild to moderate Alzheimer's Disease. This phase 3, randomized, double-blind, placebo-controlled study aims to assess how well this combination works compared to placebo in improving cognitive function and overall condition in affected adults aged 60 to 85 years. Participants will receive either the active drugs KarXT plus KarX-EC or a placebo following a specified dosing schedule. The study lasts 24 weeks, during which participants will be randomly assigned to one of these two groups. The trial is designed to carefully monitor effects and side effects of the treatments under controlled conditions. Throughout the study, participants and their caregivers will attend regular visits where cognitive tests like the ADAS-Cog11 and CIBIC+ will be conducted to track changes from baseline. Additional assessments include daily living activities, neuropsychiatric symptoms, safety labs, vital signs, ECGs, and adverse event monitoring. Caregivers will help report on participant condition and medication adherence, supporting comprehensive evaluation of the treatment's impact over the 24-week period.

Age: 60Years - 85YearsAll GendersPhase 3
126 locations
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Actively Recruiting

Researchers are studying familial hypercholesterolemia and related lipid disorders to improve treatment and reduce cardiovascular risks. The study aims to enhance lipid disorder management by partnering with primary care providers and using electronic health records to identify high-risk patients. The goal is to develop a prevention model that integrates treatment guidelines at the practice level, focusing on lowering LDL cholesterol levels in affected individuals. Participants with high LDL-C levels, especially those with familial hypercholesterolemia or related conditions, will receive supportive care through a comprehensive outreach approach. This includes database screening, secure communication with healthcare providers, genetic testing encouragement, education, medication adherence support, routine lab testing, specialist referrals, and follow-up visits either in person or virtually. Additional consultations with pharmacists, nutritionists, genetic counselors, or specialists may be provided to manage coexisting conditions. During the study, patients' LDL-C levels will be monitored, with the primary measure being the proportion maintaining LDL-C below 100 mg/dL six months after enrollment. Secondary outcomes include achieving LDL-C levels below 75 and 55 mg/dL. The study involves ongoing medical management, routine lab tests, and access to integrated care resources, aiming to improve lipid control and reduce cardiovascular risks over time.

Age: 18Years - 120YearsAll GendersPhase Not Applicable
2 locations
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Actively Recruiting

Researchers are conducting a screening study to identify individuals who may be eligible for interventional Alzheimer's disease studies sponsored by Hoffmann-La Roche. This Phase 3 study focuses on assessing potential participants based on biomarker status and cognitive function to determine suitability for future clinical trials. Participants are adults aged 50 to 90 years who have reported memory concerns within the past year, with or without a prior diagnosis of mild cognitive impairment or dementia due to Alzheimer's disease. During this study, participants will not receive any treatment but will undergo blood tests to measure the concentration of pTau217, a biomarker associated with Alzheimer's disease. They will also complete the International Shopping List Test (ISLT) to evaluate their cognitive abilities. This screening process helps to identify those who may qualify for subsequent interventional studies addressing Alzheimer's disease. Participants will be involved in blood sampling and cognitive testing at the start of the study to collect baseline biomarker and cognitive data. Researchers will monitor the concentration of pTau217 in the blood and the cognitive scores from the ISLT as primary outcome measures. The study is designed to safely assess eligibility and guide enrollment into future clinical trials, with participation lasting through the initial screening visit.

Age: 50Years - 90YearsAll GendersPhase 3
211 locations