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NCT05592678
The goal of this clinical trial is to demonstrate potential improvements in clinical trial methods relating to dementia and cognitive decline. The main questions it aims to answer are: * Can an intervention's outcome be better assessed by a latent variable ("δ") integrating cognitive performance with functional status? * Can latent biomarkers of δ guide the selection of an intervention that will modulate dementia severity? * Can a latent variable, derived from information collected remotely from caregivers, preselect subjects most likely to respond to the intervention? * Is the effect of the intervention in fact medicated by changes in the targeted biomarker? In this case, the biomarker will be a latent variable derived from several proteins measured in blood (i.e., so-called "adipokines"). The intervention will be donepezil, a medication approved for the treatment of Alzheimer's Disease, but only recently associated with adipokine changes. Participants with cognitive impairment and their caregivers will be interviewed by telephone and those newly prescribed donepezil by their provider for cognitive impairment will be recruited and enrolled. On the basis of the caregiver's report, the cognitively impaired subjects will be assigned to two groups based on a prediction of their response to donepezil. Researchers will compare those groups to see if dementia severity, as measured by δ, improves in predicted responders, and whether the change in the d-score is mediated by changes in adipokines.
NCT07529015
The goal of this clinical trial is to determine whether acoustic stimulation during sleep can enhance slow-wave sleep (SWS), improve cognitive function, and reduce AD-related pathology in individuals with mild cognitive impairment (MCI), compared with cognitively healthy participants. The main questions it aims to answer are: 1. Does acoustic stimulation increase SWS (e.g., slow oscillation and sleep spindle activity) in individuals with MCI? 2. Does enhancing SWS lead to improvements in memory and cognitive performance? 3. Does acoustic stimulation influence plasma p-tau217 levels as a marker of underlying Alzheimer's disease pathology? Researchers will compare participants receiving acoustic stimulation during sleep with those not receiving stimulation to evaluate its effects on sleep architecture, cognition, and plasma biomarkers. Participants will: * Undergo sleep recordings to assess sleep architecture, including SWS, slow oscillations, and sleep spindles * Receive acoustic stimulation during sleep across multiple nights * Complete cognitive assessments, particularly memory-related tasks * Provide blood samples to measure plasma p-tau217 levels * Provide clinical and demographic information for analysis
NCT07458620
Official Title Prospective Single-Arm Safety Study of Cervical Lymphaticovenular Anastomosis (LVA) in Patients with Alzheimer's Disease Purpose of the Study Researchers are conducting this study to see if a minimally invasive microsurgery, called Cervical Lymphaticovenular Anastomosis (LVA), is safe for people with Alzheimer's Disease. How the Surgery Works Alzheimer's Disease is linked to the buildup of metabolic waste products (certain proteins) in the brain. Recent medical discoveries show that these wastes normally drain through small channels in the neck into the blood system. In this study, surgeons will use high-powered microscopes to connect these drainage channels (lymphatic vessels) in the neck directly to small nearby veins. The goal is to create a "detour" that helps the brain clear out these harmful proteins more effectively. What to Expect Safety First: The main goal is to find out if the surgery is safe and well-tolerated by patients. The Procedure: The surgery is performed under general anesthesia and typically takes 4 to 6 hours. It involves small (about 5 cm) incisions on both sides of the neck. Follow-up: Participants will be monitored for at least 12 months. Researchers will use memory tests, brain scans (MRI and PET), and blood tests to see if the surgery helps with daily activities or slows down memory loss.
NCT07419022
Older adults and their care partners will participate in music therapy sessions for approximately 8 weeks. Before and after the 8 week study period, participants will fill out questionnaires about their mood, stress levels, and emotions. During the music therapy sessions, they may be observed or asked questions about the music therapy sessions.
NCT07422857
This study is to evaluate the efficacy and safety of \[18F\]-APN-1607 Injection in PET imaging for detecting AD-related cognitive impairment.
NCT07307872
The ADCHIP study (ST0067) is a non-interventional, monocentric, prospective study conducted by Amoneta Diagnostics and the Leenaards Memory Center (Lausanne, Switzerland). Its main objective is to develop and validate a microfluidic chip-based protocol that stabilizes human red blood cells for several weeks, enabling subsequent testing of blood biomarkers for Alzheimer's disease (AD) diagnosis. This proof-of-performance study will include 150 well-characterized participants divided equally into three groups: 50 patients with Alzheimer's disease (AD), 50 with non-Alzheimer neurodegenerative diseases (NAD, including Parkinson's disease and frontotemporal dementia), and 50 healthy controls (HC). The primary objective is to assess the diagnostic performance (sensitivity and specificity) of two main blood-based biomarkers-amyloid-β (Aβ) and protein kinase C (PKC)-measured using Amoneta's proprietary fluorescent assays and chip-cytometry technology. The secondary objective is to evaluate emerging biomarkers (proteins, RNA signatures, metabolomic and lipidomic profiles) for Alzheimer's disease detection. No therapeutic intervention will be administered; only biological samples (blood and urine) will be collected. Results will be compared with existing clinical, imaging, and cerebrospinal fluid (CSF) biomarkers. The study aims to provide a reliable, non-invasive, and affordable blood test for early Alzheimer's diagnosis, with potential applications for patient stratification and therapeutic monitoring in future clinical trials.
NCT06114745
To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-1707 in patients with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD for 26 weeks.
NCT06891716
The goal of this clinical trial is to test whether we can reliably and safely measure the accumulation of pathological protein TDP-43 \[involved in rare forms of dementia such as frontotemporal dementia (FTD) and in amyotrophic lateral sclerosis (ALS)\] using a new positron emission tomography (PET) tracer called \[18F\]ACI-19626. Both healthy people and people with (suspected) TDP-43 accumulation will participate to this trial. The main questions it aims to answer are: * whether \[18F\]ACI-19626 is safe and well tolerated when injected into participants * whether \[18F\]ACI-19626 reliably detects abnormal TDP-43 in the brain using PET technique. * whether there are differences in the amount of this protein between people with diseases related to TDP-43 accumulation in the brain and people without these diseases. Participants will: * Visit the clinic to consent to their participation and to ensure they are eligible (physical and neurological examinations, questionnaires, blood and urine tests, ECG and MRI in some cases). * Visit the clinic to receive the tracer \[18F\]ACI-19626 intravenously and be scanned in a PET scanner, during which blood will be collected. * Receive a phone call from the clinic 2 to 4 days after the PET scan to report any symptoms and side-effects that they may be having. Some of the participants may be asked to come again to the clinic for a second PET scan, allowing the researchers to determine if the measurements with the first PET scan are stable and reproducible.
NCT04570761
Alzheimer's disease (AD) is a neurodegenerative disorder affecting almost 6% of the world's population over the age of 65. This disease, in its most typical sporadic form, is characterized by an episodic memory impairment linked to a deficit in consolidation. Many studies indicate that sleep promotes this consolidation stage during the deep slow sleep stage by facilitating the transfer of information between the hippocampus and the neocortex. A method of acoustic brain stimulation at night by pink noises has been recently developed and has shown its effectiveness in strengthening memory consolidation in healthy volunteers. Actually, there is no study observing the effect of this new stimulation method on populations with neurodegenerative pathologies, in particular in AD for which this technique could potentially become a therapeutic option. The hypothesis is that of a strengthening of the memory consolidation capacities in subjects with AD as has been shown in healthy subjects.
NCT04311281
The primary objective of this study is to demonstrate the safety and efficacy of positron emission tomography (PET) imaging with a radioactive compound called \[F-18\]FDDNP in subjects with suspected Alzheimer's disease or suspected chronic traumatic encephalopathy (CTE) to predict clinical decline after one and two years.
NCT02681172
This phase 4 study will explore, in the context of the present French clinical practice, the impact of florbetaben 18F (FBB) in patients evaluated for AD who require a biomarker for etiologic determination of the cognitive and functional impairment, but in whom: 1. lumbar puncture was not feasible for medical conditions 2. results of cerebrospinal fluid (CSF) analysis were considered ambiguous by treating physicians 3. lumbar puncture (LP) was refused by the patient
NCT02531360
The overall goal of this imaging trial is to characterize \[18F\]MNI-815, a PET radioligand for imaging Tau.
NCT02103894
The goal of this study is to assess \[18F\]MNI-777 PET imaging as a tool to detect tau pathology in the brain of individuals who carry a clinical diagnosis of a tauopathy, including: Alzheimer's Disease (AD),Parkinson's disease (PD) Progressive Supranuclear Palsy (PSP), chronic traumatic encephalopathy (CTE) and Frontal Temporal Dementia (FTD) and age- and gender-matched healthy subjects.