Effect of Exercise, Endocannabinoids and Ketones on Cerebral Metabolism in a Cognitive Disorders...
Parkinson DiseaseAlzheimer DiseaseA two months intervention in which two groups of cognitive disorders, Parkinson and Alzheimer's disease, will receive 50g/day of a commercial MCT supplement combined with supervised aerobic exercise 3 times/week. Cognition and ketones will be assess before and after the intervention, along with endocannabinoids plasma concentrations.
Exploratory Evaluation of [11C]MPC6827
Neurodegenerative DiseasesAlzheimer Disease1 moreThis is a phase 0 study that will enable an assessment of biodistribution and estimation of absorbed dose in humans based on data collected from five healthy volunteers, which is typically the minimum number required by the FDA for first-in-human studies to assess dosimetry of a new tracer. The evaluation of the brain imaging of thirty additional subjects in the 2nd part of the study will lead to a descriptive assessment of the targeting and pharmacokinetics of MPC6827 in the brain and between normal and diseased brain.
β-AARC: Cohort Study for the Identification of Blood-based Biomarkers in a Population With Subjective...
Alzheimer DiseasePreclinical Alzheimer1 moreThe overall (cross-sectional) objective of this study is to detect and describe the profile of AD-related blood biomarkers in a population with SCD (including individuals with MCI) with the ultimate goal of investigating their capacity to predict underlying AD pathology. Longitudinally, the β-AARC_BBRC2021 study fundamentally aims at assessing the ability of AD-related blood-based biomarkers to predict disease progression in the Alzheimer's continuum. To achieve these cross-sectional and longitudinal objectives, an exhaustive set of clinical, risk factors, cognitive, mental health and neuroimaging data will be collected, as well as blood and CSF samples, from which AD-related fluid biomarkers will be determined. As a secondary objective, we will investigate the efficacy and accuracy of the Altoida NMI as a novel digital biomarker for identifying patients with SCD or MCI that have underlying AD pathology (cross-sectionally) and to test the capacity of the Altoida NMI to track disease progression in these popoulations (longitudinally).
Trial-Ready Cohort-Down Syndrome (TRC-DS)
Down SyndromeAlzheimer Disease1 moreThe purpose of the Trial-Ready Cohort - Down Syndrome (TRC-DS) is to enroll 120 healthy adults with Down syndrome (DS), between the ages of 25-55, into a trial ready cohort (TRC), and up to 250 participants in total including co-enrolled in the Alzheimer Biomarkers Consortium - Down Syndrome (ABC-DS) study. Participants enrolled in the TRC-DS will undergo longitudinal cognitive and clinical assessment, genetic and biomarker testing, as well as imaging and biospecimen collection. Using these outcome measures, researchers will analyze the relationships between cognitive measures and biomarkers of Alzheimer's disease (AD) to identify endpoints for AD clinical trials in DS that best reflect disease progression. To learn more about the study and participating sites, visit our study website at: https://www.trcds.org/. TRC-DS is collaborating with the Alzheimer's Disease Biomarker Consortium-Down Syndrome (ABC-DS) to allow study participants to be concurrently enrolled in both ABC-DS and TRC-DS, referred to as "co-enrollment". ABC-DS is a longitudinal, observational research study that is overseen at University of Pittsburgh Coordinating Center. ABC-DS participants who express interest in potentially joining a clinical trial in the future and who meet TRC-DS eligibility criteria, may choose to co-enroll in TRC-DS at an ABC-DS Site. Co-enrolled participants will adhere to the ABC-DS protocol and schedule of activities, but agree to share their data with the TRC-DS team and to receive invitations for future participation in clinical trials. Fore more information on ABC-DS please visit https://www.nia.nih.gov/research/abc-ds or http://abcds.pitt.edu/.
Caregiver Solutions for Dementia Patients
Alzheimer's DiseaseDementia2 moreThe goal of this clinical trial is to test a mobile application amongst caregiver's supporting patients diagnosed with Alzheimer's Disease and Related Dementias (ADRD). The main question it aims to answer is: Will caregivers supporting patients diagnosed with ADRD utilize a mobile application to routinely report symptoms of the patients they care for?
Lemborexant for Insomnia in a Patient With Dementia: An N-of-1 Trial
InsomniaDementia1 moreInsomnia is a highly common, chronic disorder that is distressful for the patient but also for caregivers and can give rise to a heavy burden on the healthcare team. Sleeping aids like benzodiazepines and other sedatives (e.g., zolpidem, zopiclone) have been widely used to help treat insomnia. However, sleeping aids are also known to cause adverse drug reactions such as drowsiness and dizziness, that increases the risk of falls, driving impairment, visual impairment, cognitive impairment, and upon discontinuation may cause paradoxical rebound insomnia, delirium, and nightmares all of which exacerbate the initial insomnia. All of the negative aspects of sleeping aid use are exaggerated for older, frail adults. Some patients experience an early (young-age) onset dementia with a substantial component of insomnia. Due to the many risks associated with traditional sleeping aids they are often inappropriate in adults living with cognitive impairment and/or frailty. Lemborexant comes from a new class of medications for insomnia. Lemborexant is a dual orexin receptor antagonist that blocks the binding of wake-promoting neuropeptides orexin A and orexin B to their receptors orexin 1 receptor (OX1R) and orexin 2 receptor (OX2R), which is thought to suppress wake drive. Unlike other traditional sleeping aids, lemborexant has not shown to be significantly associated with driving impairment, rebound insomnia, or dependence/withdrawal symptoms. Also, in clinical trials it only rarely causes the types of adverse events associated with benzodiazepines and other traditional sedatives and is less often associated with discontinuations due to adverse events. While lemborexant is available on the Canadian market it is unclear how this medication will be tolerated by patients living with an early onset dementia. Understanding the effectiveness and tolerability of lemborexant will be helpful in an N of 1 trial to understand the details of effect and effectiveness in individual patients.
Efficacy and Safety of GSK4527226 [AL101] in Participants With Early Alzheimer's Disease
Alzheimer's DiseaseThe aim of this study is to assess the efficacy and safety of GSK4527226 in participants with early Alzheimer's Disease (AD) (including mild cognitive impairment [MCI] and mild dementia due to AD) of 2 dose levels of GSK4527226 compared to placebo.
Smart Lighting for Nursing Home Residents With Dementia
Alzheimer's Disease and Related DementiasThis proposed study seeks to develop a smart ambient bright light (SABL) intervention to provide auto-controlled, consistent indoor lighting that incorporates natural daylight. This SABL includes tunable LED lights, photosensors, and controllers. The SABL system has a pre-programmed 24-hour control schedule for illuminance settings to mimic the natural bright-dark cycle. It will automatically adjust the lights to accommodate the daylight effect to minimize staff burden and maximize the LI effect. The SABL will be installed in participants' bedrooms and designated areas in the dining rooms and activity rooms for four weeks. Each participant will wear a personal light monitor to measure the lighting dosage each participant receives. This study will address three aims: 1) pilot test the effect of SABL on reducing agitation in persons with ADRD, 2) evaluate the fidelity of the SABL delivery, and 3) evaluate the feasibility of implementing the SABL. The study will be conducted in two NHs in Pennsylvania. For aims 1 and 2, the investigators will use a crossover, cluster randomized control trial (RCT) and will enroll residents with ADRD and agitation. For aim 3, the investigators will use a mixed methods design and will interview NH stakeholders to evaluate the acceptability, feasibility, and appropriateness of the intervention. This is the first study that incorporates daylight in ambient light interventions and the first study that addresses the measurement, feasibility, and fidelity of lighting interventions. Findings will establish evidence-based implementation strategies and the best design for SABL to reduce agitation for persons with ADRD in NHs.
Memory and Social Interactions
Alzheimer DiseaseSemantic DementiaMemory and social interaction are intimately linked. On the one hand, social interaction is a privileged context for learning, and on the other hand, appropriate social interactions involve remembering the partners encountered and previous exchanges. People with Alzheimer's disease classic syndrome variant (AD) have a major impairment of episodic memory, while people with the semantic variant of primary progressive aphasia (SPPA) are characterized by semantic disorders in the foreground, associated with changes in their social behavior with a tendency to egocentricity. In both cases, patients frequently have reduced social interactions. Although social interaction situations seem to constitute a privileged learning context, their effectiveness for patients with cognitive disorders must be evaluated and the conditions under which they are effective must be established. The main objective of this study is to determine whether social interaction constitutes a beneficial context for learning new information and whether the presence of social behavior disorders alters this benefit. More broadly, the goal is to better understand the mechanisms underlying the possible beneficial effect of learning in social contexts and to clarify the links between memory performance in different social contexts, cognitive disorders, social behavioral changes and personality traits. Finally, a description will be made of the brain substrates associated with memory performance obtained during learning in social contexts in order to investigate their particularities. Thirty couples each including a person with AD, 16 couples each including a person with SPPA and 46 couples of persons without cognitive complaints (HC), one of which will be matched in gender and age to one of the patients, will be included in the study. Participants will perform image location learning in a grid, in three social contexts in which both members of the couple are involved: 1) simple presence of others, 2) by observation and 3) in collaboration. A psychometric assessment including social cognition and classical tests assessing memory, and questionnaires concerning global executive functioning, social behavior and personality will be offered to all participants. Patients in the AD and SPPA groups and the matched individual in the HC group will undergo anatomical and functional brain magnetic resonance imaging (MRI).
CBD for Individuals at Risk for Alzheimer's Disease
Mild Cognitive ImpairmentThis is a double-blind, randomized controlled trial designed to test the effects of cannabidiol (CBD) on validated biomarkers of Alzheimer's disease (AD) progression, behavioral and clinical measures, with putative mechanisms of CBD action.