View clinical trials related to Alzheimer Disease.
Filter by:In humans, insulin is secreted in pulses from the pancreatic beta-cells, and these oscillations help to maintain fasting plasma glucose levels within a narrow normal range. These pulses become disrupted in the presence of insulin resistance. Some people have referred to Alzheimer's Disease as type 3 diabetes because the glucose uptake in the brain is reduced by 30%. Clinical observations in clinics that treat patients with insulin pulses every 5 minutes for 3 hours twice a week for 2 weeks followed by once a week for 6 weeks and followed by less frequency treatments suggest an improvement in type 2 diabetes control, reduction in insulin resistance and an improvement in diabetes complications. A patient with Parkinson's Disease was treated with this pulsed insulin paradigm and experienced dramatic improvement that has now been maintained over years. Parkinson's Disease has been reported to have a decreased glucose uptake in the brain, so pulsed insulin treatment was tried in a small number of patients with Alzheimer's Disease and there was an impression that they showed improvement. Clinics that use pulsed insulin treatment change more than one parameter of the insulin pulses which makes it difficult to determine what is giving the improvement. The euglycemic hyper-insulinemic clamp, also called a clamp, is a well-standardized test that measures insulin resistance and involves intravenous insulin infusion. This single patient study will enroll one patient with early Alzheimer's disease and insulin resistance. The subject will have one standard clamp test with continuous insulin followed by 4 clamps over a 2-week period using the same amount of insulin over the same period of time but administered in pulses every 5 minutes. This was the number of pulsed insulin treatments needed to see a dramatic improvement in Parkinson's disease. The cognition in the Alzheimer's disease patient will be thoroughly evaluated with questionnaires and walking on a special mat while doing arithmetic tasks before and after the 4 pulsed insulin clamps. If this study demonstrates an improvement in cognition, one will know that the only thing that changed from the standard clamp was the pulse nature of the insulin delivery.
The APEX study is a multicenter, observational study designed to capture longitudinal follow-up of plasma biomarkers and cognitive and functional assessments on individuals who screen failed in the AHEAD study over approximately 4 years. Approximately 1000 participants will be enrolled across three groups: - Group A: Approximately 500 participants who are discordant on screening (plasma positive / Positron Emission Tomography (PET) negative), - Group B: Approximately 250 participants who are concordant on screening (plasma negative / PET negative), and - Group C: Approximately 250 participants selected from the individuals who previously screen failed prior to PET for the AHEAD study with oversampling of racial and ethnic populations underrepresented in Alzheimer's disease (AD) clinical trials. Primary Objectives: - Collect longitudinal cognitive and functional assessments and blood-based biomarker data - Evaluate, characterize, and compare the longitudinal cognitive and functional data between the three groups of participants - Compare longitudinal change across race and ethnicity, sex, and Apolipoprotein E (ApoE) status Exploratory Objectives: • Collect baseline amyloid PET on participants without prior amyloid PET data (Group C)
This project aims to understand the feasibility, acceptability and real-world evidence of a novel UK-based remote brain health clinic for patients with mild cognitive impairment (MCI). A timely and accurate diagnosis of dementia is a priority in the UK and MCI is indicative of future risk of cognitive decline. An accurate etiological diagnosis of MCI (MCI-subtyping - distinguishing those who are likely to go on to develop dementia and those who are not) is vital for treatment planning. Whilst the assessment of molecular biological markers (biomarkers) for etiological diagnosis of MCI and Alzheimer's disease (AD) is increasingly recommended and employed internationally, the uptake is low in UK memory clinics. The Brain Health Clinic (BHC) has been specifically designed as a state-of-the-art diagnostic centre for those with MCI. Procedures will include a range of clinical and biomarker assessments, with molecular biomarkers based on lumbar puncture and cerebrospinal fluid (CSF) analysis. Additionally, the clinic will employ remote neuropsychiatric assessments using digital and telephonic methods. This allows for regular contact, whilst adhering to changes in clinical practice and national guidance due to the COVID-19 pandemic. Our overarching objectives are to first establish the acceptability and feasibility of the remote Brain Health Clinic and its novel clinical and biomarker assessment programme. Then secondly establish the impact of care under the Brain Health Clinic on i) care management decisions (e.g. follow-up and treatment planning); ii) time to etiological diagnosis of MCI (MCI-subtyping); and iii) time to diagnosis of dementia and severity of dementia at the time of diagnosis.
This study is being conducted to evaluate the long-term safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is an open-label trial of treatment with ALZ-801.
Available FDA approved treatments for Alzheimer's disease (AD) temporary alleviate symptoms but have no bearing on overall disease progression. However, recent FDA approval of lecanemab (July 2023), a disease modifying therapy based on a phase 3 clinical trial demonstrated efficacy (cognitive) in persons with AD. Delaying the disease progression may impact not only the person living with dementia (PLWD), but also their Care Partners. It may provide the ability to achieve "life goals" as a family or may increase/reduce stress and burden on the family due to the complexity of the treatment regimen. Recent secondary analysis of this Phase 3 trial suggests quality of life showed less decline in PLWD and less increase in burden in Care Partners. The investigators propose to create a registry/database for persons living with dementia who receive lecanemab infusions at HealthPartners and their Care Partners. The investigators plan to test the feasibility of collecting outcomes data for specific patient and family focused outcomes, and outcomes that are typically not included in clinic. The outcome of this study will help in the overall goal of studying the impact of lecanemab in real-world settings in a larger cohort of PLWD and Care Partners.
The goal of this observational study is to determine whether the early adoption of blood-based biomarkers for Alzheimer's disease is associated with an impact on etiological diagnosis, patient's management, emotional impact, patient's preferences and cost-effectiveness in patients presenting with cognitive complaints in a Cognitive Disorders Unit from a public hospital. The main questions it aims to answer are: 1. Does the early adoption of blood-based biomarkers in clinical practice enable an earlier etiologic diagnosis with high confidence compared to the late adoption of blood-based biomarkers in the patients with cognitive complaints that are admitted in a Cognitive Disorders Unit? 2. Is the early adoption of blood-based biomarkers in clinical practice associated with changes in clinical management compared to their late adoption? 3. Is the early adoption of blood-based biomarkers in clinical practice associated with a lower emotional impact in the patients and their study partners/caregivers compared to their late adoption? 4. Are blood-based biomarkers better tolerated than other tests and preferred by patients for the diagnostic work-up? 5. Does blood-based biomarkers have an impact in the cost of the diagnostic workup and clinical management of the patients that are admitted in a Cognitive Disorders Unit? Participants will be asked to: - Perform a blood extraction for blood-based biomarkers analysis at the beginning of the study. - Complete specific scales in each visit. Researchers will compare the group in which blood biomarkers are delivered at 3 months with the group in which they are delivered at 9 months to assess whether early adoption of blood-based biomarkers is associated with an impact on etiological diagnosis, patient's management, emotional impact, patient's preferences and cost-effectiveness in a specialized memory unit.
This is an open-label extension for a multicenter, randomized, double-blind, sham-controlled, adaptive design pivotal study. Participants who complete the Hope Study (CA-0011) will be eligible to consent for screening to enroll in the OLE Hope Study (CA-0015). All participants will be treated with an Active Sensory Stimulation System (GS120) for 60 minutes daily for up to 12 months. There will be no Sham treatment group or randomization involved in this study.
In the ADDITION-MCI project, patients with a diagnosis of mild cognitive impairment probably caused by Alzheimer's disease will receive plasma exchange.
The goal of this clinical trial is to evaluate the effectiveness of integrating Snoezelen methods with aromatherapy and personal items in reducing agitation in Arab elderly individuals with dementia. The main questions it aims to answer are: Does the combination of Snoezelen methods, aromatherapy, and the use of personal items significantly reduce agitation in elderly Arab patients with dementia compared to standard care practices? How do patients and caregivers perceive the impact of this integrated approach on the overall well-being and quality of life of the patients? Participants in this study will: Engage in sessions utilizing Snoezelen methods, a multi-sensory environment designed to deliver stimuli to various senses. Receive aromatherapy treatments with selected scents known for their calming properties. Be provided with personal items that are familiar and meaningful to them, to create a sense of comfort and security.
This 52-week, open-label extension study is to evaluate the long-term safety and tolerability of ACP-204 in subjects with ADP.