Active clinical trials for "Alzheimer Disease"

This study is to evaluate the safety and tolerability of single dose of GB-5001 (donepezil) IM depot in healthy male volunteers. And, it is to predict the multiple-dose pharmacokinetics based on the single-dose pharmacokinetics of GB-5001 IM depot and the oral Aricept® (donepezil hydrochloride) tablet by PK modeling.

As part of Phase II of the NIH SBIR grant, the study will conduct a randomized controlled clinical trial in which the MapHabit system (MHS) will offer a caregiver training product that is linked to MHS, an Alzheimer's disease or related dementias (AD/ADRD) assistive technology product that uses visual maps to improve a patient's behavior and sense of autonomy. MapHabit's combined areas of focus, i.e., offer a single integrated product to address the caregiver and the person under this caregiver's care, are unique and will create a new standard in the field to reduce caregiver burden in the setting of caring for individuals with AD/ADRD. Additionally, the study will integrate enhanced user support modules, i.e., gamifying, dashboarding, and social networking, to improve the Caregiver Training Program (CTP) experience.The study will be a randomized controlled clinical trial, in which two conditions will be investigated: 1) control condition in which the MHS alone is incorporated in the participant's daily care and 2) experimental condition in which the MHS+CTP is implemented into the daily care received by participants. The sample size will be a total of 50 patient-caregiver dyads, 25 in each condition. The study duration will be a 6-month intervention.

The importance of the proposed study concerns the understanding of the way in which each drug acts in each organism separately, both at the genome level and at the microbiome level. It is often observed that various treatments do not have the expected results in all patients, while, at the same time, new pathophysiological mechanisms for each disease are found. The involvement of the intestinal microbiome is one of these mechanisms and as it affects not only the progression of the disease but also the way in which drugs are metabolized (hence their action) should now be considered in every possible case. This led to the emergence of a new field of study related to personalized medicine, pharmacomicrobiomics. It includes microbiology, genomics, and pharmacology, and studies the changes that the human microbiome shows in drug exposure, action, and toxicity. However, this field is relatively new, and although there have been several reports of microbial biotransformation, there has been little in-depth research into the specificity of bacterial strains or the factors that can predict drug transformations. Therefore, this study will give the impetus for the individualized treatment, which will not only concern the genome (which is constantly evolving in recent years) but also the intestinal microbiome, which as mentioned above, is involved in many pathological conditions. Importance of the study Although a considerable number of studies have focused on the relationship between the microbiome and the pathogenesis of Alzheimer's Disease (AD), we have not seen any studies on the effect of drugs currently used in the treatment of AD (which are primarily cholinesterase inhibitors), such as rivastigmine, galantamine and donepezil and the NMDA (N-methyl-D-aspartate) glutamate receptor antagonist (memantine). There is also no reference to the composition and / or activity of the microbiome or to the effect of the latter on the pharmacokinetics and / or pharmacodynamics of these drugs. Also, although the human microbiome is influenced by genetic factors in the body, the effect of polymorphisms on the P-gp gene, which is involved in the pathophysiology of AD, the microbiome or its metabolites, has not been studied.

Clinically Designed Improvisatory Music (CDIM) is a form of improvised music based on calm-inducing sound parameters which brought relief to our cohort of neurology patients. As a direct sound-based approach, CDIM does not rely on autobiographical memory and may have wider applicability and generalizability. We wish to examine if CDIM decreases anxiety in 15 cognitively healthy individuals and 15 Alzheimer Disease patients with anxiety (AD-A).

The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of MK-8189 in participants with Alzheimer's Disease (AD) with or without symptoms of agitation-aggression and/or psychosis.

The SAD design of the study is based on the aim to study safety, tolerability and PK of selected doses of ACD856 in a limited number of healthy volunteers. ACD856 will be administered orally.

This study aims to examine the safety and efficacy of suvorexant (MK-4305) to improve sleep in individuals with Alzheimer's disease (AD). The primary hypothesis for the study is that suvorexant is superior to placebo in improving insomnia as measured by change from baseline in polysomnography (PSG)-derived total sleep time (TST) at Week 4.

This study evaluates the side effects of dose escalation in the treatment of donepezil 23mg for patients with Alzheimer's disease. Investigators randomly divide participants into three groups according to the dose escalation method; no titration, 15mg of donepezil for a month before escalation to 23mg, and alternating of 10mg and 23mg for a month before escalation to 23mg.

The study is a randomized, parallel, 4-dose design in subjects with mild-to-moderate Alzheimer's Disease. Subjects will be randomized to one of 4 doses of T3D-959. Subjects will be evaluated for changes from baseline in cerebral metabolic rate of glucose (FDG-PET imaging), functional connectivity of the hippocampus (BOLD-fMRI), and cognitive function (ADAS-Cog11 and DSST) as well as assessed for safety and tolerability to T3D-959. An expanded access extension is planed to provide access to study medication to subjects who have completed the main study and requested continued use.

Specific Aim 1: To determine feasibility of a 20-minute dyadic exercise program for ambulatory individuals with dementia and caregivers living at home based on recruitment, adherence and retention. Investigators will conduct a pilot randomized controlled trial (RCT) with 20 dyads (total N = 40) in groups of 5 randomized to 16-week group exercise classes and regular home practice or wait list in a cross-over design. Investigators will assess feasibility of enrollment and retention, the proportion of completed outcome measures, and adherence by class attendance logs, caregiver-reported home practice logs and qualitative interviews to assess ease of implementation in the home environment. Investigators will explore feasibility of weekly phone calls to (potentially overwhelmed) caregivers and Fit-bit accelerometers as a measure for tracking home practice. Specific Aim 2: To collect preliminary effect size data for sample size calculation for a larger trial. Investigators will assess standard outcomes (such as the Short Physical Performance Battery and Alzheimer's Disease Assessment Scale - cognitive subscale as primary outcomes for affected individuals; and Caregiver Burden Inventory for caregivers) commonly used in pharmacological studies of individuals with dementia at baseline, 16 and 32 weeks and calculate effect sizes (Cohen's d) for between-group differences in outcome changes in the 20 dyads of the RCT described in Specific Aim 1. Specific Aim 3: To explore the feasibility of using non-invasive Near-Infrared Spectroscopy (NIRS) to assess regional cortical brain oxygenation and its sensitivity to change. Investigators will compare brain oxygenation variations before and after the exercise intervention during a memory task for the seniors with dementia.