A Clinical Trial of AAV2-BDNF Gene Therapy in Early Alzheimer's Disease and Mild Cognitive Impairment...
Alzheimer's DiseaseMild Cognitive ImpairmentThis is a first-in-human clinical trial to test whether a protein administered into the brain continuously by gene therapy, Brain-Derived Neurotrophic Factor (BDNF), will slow or prevent cell loss in the brains of people affected by Alzheimer's disease and Mild Cognitive Impairment. The protein may also activate cells in the brain that have not yet deteriorated. Gene therapy refers to the use of a harmless virus to have brain cells make the potentially protective protein, BDNF.
Applying Non-invasive Brain Stimulation in Alzheimer's Rehabilitation
Alzheimer DiseaseMild Cognitive ImpairmentPresently, few studies have evaluated the clinical impact of rTMS in Alzheimer's disease. Though some studies have demonstrated an improvement, there have been conflicting results, as others do not seem to demonstrate beneficial effects. Furthermore, it is the combined application of rTMS with cognitive training that could represent a real turning point in interventions aiming to slow down cognitive decline resulting from AD. Research has shown that the best way to promote the strengthening of a network is to stimulate the area while simultaneously activating the network (i.e. through cognitive training) which supports the specific function of interest. Recently, there have been new protocols from animal model research showing that "bursts" of repetitive stimulation at a high theta frequency induce synaptic plasticity in a much shorter time period than required by standard rTMS protocols. This type of rTMS stimulation, theta-burst stimulation (TBS), is therefore even more compelling as a therapeutic intervention given that it includes the benefits previously ascribed to other rTMS protocols, but requires less administration time. Furthermore, studies conducted using both types of stimulation suggest that TBS protocols are capable of producing long term effects on cortical excitability that exceed the efficacy of those using standard rTMS protocols. This project offers patients the possibility of accessing an innovative non-invasive, and non-pharmacological treatment. The goal is to evaluate the clinical efficacy TBS in patients diagnosed with mild cognitive decline (MCI) and AD, verifying if TBS in conjunction with cognitive training produces results better than those obtainable with only one of the two methodologies alone. Patients will be evaluated throughout the full scope of the treatment period, through clinical assessments and neuropsychological evaluations. We will examine neuroplastic changes by investigating the neural correlates underlying improvements using the multimodal imaging technique: TMS-EEG co-registration. A secondary objective will be to define the most effective stimulation protocol, verifying if TBS applied continuously (cTBS) or intermittently (iTBS) produces better behavioral outcomes. The results will be crucial to gain a better understanding of the mechanisms through which brain stimulation contributes to the promotion of neuroplasticity, and the efficacy of TBS combined with cognitive training.
Efficacy and Safety of Yangxue Qingnao Pills in the Treatment of Mild to Moderate Alzheimer's Disease...
Alzheimer DiseaseYangxue Qingnao Pills1 moreAs a traditional Chinese medicine compound, Yangxue Qingnao Pills is proven to have beneficial effects on learning and memory ability in animal models of Alzheimer's disease(AD). The purpose of the study is to evaluate the efficacy and safety of Yangxue Qingnao Pills on patients with mild to moderate AD. This phase II randomized, double-blind, parallel controlled trial include a 2 weeks run-in period, and a 48 weeks double-blind treatment period of after randomization. Participants will be randomly allocated to Yangxue Qingnao pills high dose group (7.5 g per time,2 times per day) ; and Yangxue Qingnao pills low dose group (5 g per time,2 times per day), or placebo group. The outcome measures include general cognitive function, ability of daily living, and behavioural and psychological symptoms in AD patients.
Effect of Transcranial Random Noise (tRNS) for Early Alzheimer's Disease
Transcranial Random NoiseElectroencephalography1 moreTo investigate the treatment effect of Transcranial random noise (tRNS) on Alzheimer patients, and the underlying neural mechanism by EEG.
dTMS for Subjective Cognitive Decline
Alzheimer DiseaseSubjective Cognitive DeclineDeep transcranial magnetic stimulation (dTMS) is a brain stimulation technique that involves generating a brief magnetic field in a coil that is placed on the scalp. The magnetic field passes through the skull and induces a weak electrical current in the brain that briefly activates neural circuits at the stimulation site. The Brainsway dTMS H7-Coil is able to target an area of the brain that has been shown in studies to be linked to greater resilience to cognitive decline. In this study, the investigators will combine dTMS with cognitive training in older adults with subjective cognitive decline (SCD) and examine the effect of this treatment on memory, other cognitive abilities, and mood. In addition, the investigators will examine the combined effects of dTMS and cognitive training on brain activity as measured using electroencephalography (EEG). Approximately 30 older adults from ages 55 to 70 with SCD and a positive family history of Alzheimer's disease will be enrolled in this study.
A Phase 2 Clinical Study to Explore the Optimal Dosage/Administration of PM012 Tablet in Alzheimer's...
Mild Alzheimer DiseaseTo evaluate the safety and efficacy of PM012 tablets for Alzheimer's disease, dose-finding study will be performed on phase 2b, and the established dose will be used for the non-inferiority phase 3 trial to evaluate the investigational product's safety and efficacy: Double blind, randomized, active drug comparative, multi-center, parallel-group clinical trial
Life Story Questionnaire and Physical Therapy Participation
Dementia AlzheimersThe goal of this clinical trial is to see the effect of life story questionnaire (LSQ) on physical therapy participation in patients with dementia. The main question[s] it aims to answer are: What is the effect of LSQ usage on physical therapy participation in people with dementia? What is the effect of LSQ usage on depression in people with dementia? What is the effect of LSQ usage on the quality of life in people with dementia? The researcher will compare these effects between the intervention group (usage of the Life Story Questionnaire) and the control group (no usage of the Life story questionnaire). All Participants will receive Physical therapy treatment as usual. The life Story Questionnaire will be used in the intervention group during physical therapy treatment. Life Story Questionnaire: It is developed by the Crisis Prevention Institute, which is a type of life story book for people with dementia. The LSQ allows caregivers to start conversations about topics that are important to each patient, can help establish rapport between the caregiver and patient.
Long-term Effect of TMS in Primary Progressive Aphasia
Primary Progressive AphasiaFrontotemporal Dementia1 moreThere are very few treatments for neurodegenerative disorders, and the efficacy of these treatments is generally modest. Recent studies have shown a short-term positive effect of non-invasive neuromodulation techniques such as transcranial magnetic stimulation (TMS) in primary progressive aphasia (PPA). PPA is a clinical syndrome associated with Alzheimer's disease and Frontotemporal degeneration. The aim of this study is to compare the effect of TMS and language therapy versus language therapy and sham TMS in patients with PPA during 6 months. A prospective, randomized, controlled, double-blind and parallel clinical trial will be conducted. The changes in brain metabolism using FDG-PET, language, neuropsychiatric symptoms, and daily-living activities will be assessed. Connectivity changes using electroencephalography will also be examined. In addition, a subgroup of patients will be assessed with multimodal MRI (structural and functional), and blood biomarkers. As a result of this project, valuable information about the long-term efficacy of non-invasive brain stimulation in PPA will be obtained, as well as the mechanisms of the therapy and clinical and neuroimaging factors associated with therapy response.
Study to Assess Adverse Events, Change in Disease Activity and How Oral ABBV-552 Capsules Moves...
Alzheimer's Disease (AD)Alzheimer's disease (AD) is a progressive, irreversible neurological disorder and is the most common cause of dementia in the elderly population. Clinical symptoms of the disease may begin with occasional forgetfulness such as misplacement of items, forgetting important dates or events, and may progress to noticeable memory loss, increased confusion and agitation, and eventually, loss of independence and non-responsiveness. This study will assess how safe and effective ABBV-552 is in treating symptoms of early AD. Adverse events, change in disease activity, how ABBV-552 moves through body of participants and the body response to ABBV-552 will be assessed. ABBV-552 is an investigational drug being developed for the treatment of Alzheimer's disease (AD). Study doctors put the participants in 1 of 4 groups (3 active dose groups and a placebo group), called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to placebo. Approximately 240 participants aged 50-90 years with mild AD will be enrolled in approximately 60 sites across the world. Participants will receive oral ABBV-552 or placebo capsules once daily for 12 weeks and followed for 30 days after the last dose of study drug. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease...
Alzheimer's DiseaseDementia6 moreThis study will investigate different donanemab dosing regimens and their effect on the frequency and severity of ARIA-E in adults with early symptomatic Alzheimer's disease (AD) and explore participant characteristics that might predict risk of ARIA.