Active clinical trials for "Alzheimer Disease"

This study is a prospective, single-center, single-arm early feasibility study, to establish safety and tolerability of LIFU for neuromodulation in patients with mild cognitive impairment ( MCI) due to Alzheimer's disease.

The pathophysiology of AD is complex. In addition to amyloid plaques and neurofibrillary degeneration, there is a metabolic alteration of the energy pathways, oxidative phosphorylation and glycolysis, which are involved in brain function. Several authors have shown a series of early metabolic dysregulations via an increase in phosphorylation at the origin of neuronal death. Ultra-high field imaging (7T MRI) may allow, with its better spatial resolution and advanced imaging techniques, to shed light on the mechanisms of progression of Alzheimer's disease. A Magnetic Resonance Spectroscopy (MRS) examination can be coupled to brain MRI without additional risk for the patient. Multinuclear 1H-31P metabolic imaging is a promising tool that can provide information on the metabolic evolutionary profile of AD. Thus, we propose a longitudinal study in patients with early-stage AD on 7T MRI-MRS.

Researchers are trying to determine the frequency of seizures and epilepsy in patients with Early-onset Alzheimer's disease (EOAD) using a 48-hour computer assisted ambulatory electroencephalogram.

African-Americans (AAs) have an increased prevalence of both Alzheimer's disease (AD) and vascular risk factors for AD such as diabetes and hypertension when compared to whites. However, in a recent community based study of non-demented elderly, black race was associated with higher amyloid burden after adjusting for vascular risk factors, suggesting the presence of additional physiological differences on AD-risk by race in the early stages of the disease. The purpose of this study is to test whether poor slow wave sleep (SWS) quantity (SWS duration) and quality (slow wave activity, SWA) is one of these physiological factors. To test these hypotheses, the investigators will perform community outreach in churches and community-based organizations in Brooklyn and other NYC boroughs with which we have created substantial ties in recent years. In consultation with community stakeholders, the investigators will recruit 150 cognitively normal AA elderly (age 60-75) and 60 age, sex, BMI, income and education matched non-Hispanic whites from the same geographical areas. Investigators will first perform a medical and cognitive evaluation (Visit 1). Participants will then undergo 2 nights of home sleep monitoring using an unattended device to exclude OSA, followed by 7 days of actigraphy with a sleep log to record sleep duration. Both devices will be returned by mail. Subjects with reported total sleep time (TST) between 5 and 10 hours and absence of moderate to severe OSA will be invited to perform a 2-night nocturnal polysomnography (NPSG) (Nights 1-2) and a PiB-PET MR scan (Visit 2).

This is a Phase 2 study assessing the safety, tolerability and efficacy of intranasal delivery of APH-1105 for the treatment of mild to moderate Alzheimer's in adult.

Alzheimer's disease (AD) is the leading cause of dementia and its prevalence is estimated to exceed 100 million affects by 2050, becoming the main public health problem worldwide. AD is considered a clinicopathological entity characterized by a progressive cognitive impairment with affectation of memory and other cognitive domains, which underlies a neuropathological pattern with extracellular accumulation of β-amyloid protein (Aβ) in the form of neuritic plaques, intracellular deposits of tau protein in the form of neuritic strands and neurofibrillary tangles, neuronal and synaptic loss and glial proliferation. Classically, its definitive diagnosis implied the existence of a clinical phenotype compatible with dementia, together with the neuropathological findings characteristic of the disease. More recently, evidence of clinical and biological changes leading to the dementia phase has led to the development of new diagnostic criteria that divide the course of AD into 3 stages: (1) a pre-clinical phase, which would include persons with positive biomarkers with normal cognitive performance for their age and educational level; (2) a phase of mild cognitive impairment (MCI), characterized by cognitive performance lower than expected by age and educational level; and (3) a dementia phase, once cognitive deficits interfere with the activities of daily living. Recent research has also shed light into the subdivision of each of the above-mentioned stages in distinct phases. For example, the existence of a subjective perception of cognitive decline or a subtle cognitive decline, have been postulated as phases within the AD preclinical stage. The lack of positive results in the different clinical trials performed to date in patients with AD dementia has redirected the focus of therapeutic strategies towards preventing the development of dementia. For this reason, a detailed characterization of the successive clinical and biological changes that lead to the dementia stage is of vital importance in identifying the persons who could benefit from a possible preventive strategy, as well as the optimal moment to carry out the intervention. The the scientific community, is convinced that intervention aiming to prevent the clinical development of AD dementia must be implemented several years before the first symptoms arise. In this context, the present project is developed under the hypothesis that subjective cognitive decline (SCD) in individuals with a performance in cognitive tests within normality represents the first symptomatic manifestation of AD. In persons with SCD, the presence of a higher intensity of subjective complaint quantified using a specific subjective complaint questionnaire (SCD-Q) will be associated with lower cognitive performance and a higher rate of conversion to MCI and/or dementia. The relationship between the perception of cognitive decline by the subject and his/her relative will differently vary depending on the stage of the disease: in subjects with progressive cognitive impairment, the subjective perception of cognitive decline will decrease with disease progression whereas the perception of decline will increase with disease progression in their relatives. The degree of perception of cognitive decline throughout the different phases of the disease will be correlated with cognitive and affective patterns as well as with changes in AD biomarkers. These changes will be related to specific brain patterns and abnormal levels of AD biomarkers, which on the other hand will also be present in patients with MCI and mild dementia due to AD. The present study has two main objectives that are: To characterize from a cognitive and biomarker (when available) point of view persons with SCD and to study its association with the risk of presenting a progressive cognitive deterioration. To study the evolution of the subjective perception of cognitive impairment by the participants and their relatives and to analyze its impact in cognitive, affective and functional terms along the clinical-biological continuum of AD.

By doing this study, researchers hope to learn how the Mediterranean and low-fat eating patterns affect memory, brain volume, brain antioxidant status and cardio-metabolic biomarkers, such as blood pressure and blood glucose, in cognitively normal older adults. Researchers also plan to examine underlying processes relating the patterns to brain health.

Alzheimer's disease (AD) clinically characterized by the cognitive impairment and lowering of various functional abilities lead to staggering costs and suffering, which are particularly related to the social impacts of caring for increasingly disabled individuals. Some of these changes can be almost undetectable in the early stages of the disease, worsening over time often and at a varying rate of progression in different people. The traditional clinical scales or questionnaires such as ADCS (Alzheimer's Disease Cooperative Study) - ADL (Activities of Daily Living) for detecting such functional disabilities are typically blunt and rely on direct observation or caregiver recall. Digital technologies, particularly those based on the use of smart phones, wearable and/or home-based monitoring devices, here defined as 'Remote Measurement Technologies' (RMTs), provide an opportunity to change radically the way in which functional assessment is undertaken in AD, RMTs have potential to obtain better measurements of behavioral and biological parameters associated with individual Activities of Daily Living (ADL) when compared to the current subjective scales or questionnaires. Divergence from normative ADL profiles could objectively indicate the presence of incipient functional impairment at the very early stages of AD. Therefore, the main hypothesis of this study is that RMTs should allow the detection of impairments in functional components of ADLs that occur below the detection threshold of clinical scale or questionnaires.

Safe and effective severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines may reduce the transmission of and achieve population immunity against the COVID-19 pandemic, which accounted for more than 3.75million deaths worldwide. With World Health Organization's (WHO) effort on ensuring equitable access to COVID-19 vaccines, vaccination rate may increase in the near future. On the other hand, vaccination hesitancy has emerged as a major hindrance on the global vaccination campaigns in certain areas due to safety concerns, social factors, and public health policies. For instance, a recent survey conducted in Hong Kong showed a low vaccine acceptance rate of 37%. Long-term safety concerns and post-vaccination events relayed by the social media maybe reasons for vaccination hesitancy. Among which, cerebrovascular accidents (CVA) after vaccination were one of the most frequently reported post-vaccination events. These reports ranged from ischemic strokes in elderly patients with multiple cardiovascular co-morbidities, to hemorrhage strokes in otherwise "young-and-fit" adults. While many of these events were investigated by the COVID-19 immunization expert committee, an important premise to address the apprehension of CVA after vaccination is the provision of evidence-based information of the impact of COVID-19 vaccines on brain health. In this prospective, longitudinal, observational study, we aim to elucidate the relationship between COVID-19 vaccines and cerebrovascular health in healthy citizens in a population-based cohort.

The CAREPATH will conduct Technical Validation and Usability (TVU) study by involving ≥ 45 target end users (16 patients with MCI or mild dementia with their informal caregivers and 16 healthcare professionals from various disciplines) and Clinical Investigation (CI) study involving ≥ 200 patients (≥ 100 users to pilot the CAREPATH platform and ≥ 100 patients as reference cases). Both of these pilot studies will be coordinated in four European countries (Spain, Romania, Germany and UK) with diverse health and social care systems, ICT landscape/digital maturity of healthcare provision and dementia national programs, which will allow for strengthening the evidence base on health outcomes and efficiency gains. The CAREPATH outcomes can be summarized as: An Integrated Care Platform that jointly addresses multimorbidity, dementia and diminished intrinsic capacity and optimally manages healthcare interventions for its users (patients, informal caregiver, healthcare providers, etc). Technical Validation and Usability (TVU) study involving over 45 users and Clinical Investigation (CI) involving over 200 patients that will be conducted in four European countries (Spain, Romania, Germany and UK) during two years and mobilizing the other necessary actors, such as caregivers and healthcare professionals, for the validation of healthcare interventions. Dementia / Multimorbidity Guidelines that will be conceived for best healthcare delivery. Health Economics Impact Assessment for healthcare cost effectiveness and care provision equalities. The incremental cost-effectiveness and the incremental cost-utility ratio would allow revealing the incremental cost (or the potential savings) per unit of benefit of switching from usual care to CAREPATH-an integrated patient-centred approach- in multimorbid elderly patients with dementia, and therefore, to determinate whether the CAREPATH approach would be considered as a cost-effective alternative.