Active clinical trials for "Cognitive Dysfunction"

A randomized, parallel-group, double-blind, exploratory two-arm trial to assess the effects of CBD on driving ability along with changes in psychological status (i.e. mood, drowsiness, sedation) and cognitive function. Forty healthy West Virginia University (WVU) students will be allocated and randomized to receive: (1) 300 mg of pure CBD oil or (N=20) (2) placebo matched in appearance and taste (N=20). After consuming the study drug, each individual will participate in a 25-35-minute driving simulation and their driving performance measured. To assess changes in psychological status (i.e. mood, drowsiness, sedation) and drug impairment-related cognitive function, the Visual Analog Mood Scale, Stanford Sleepiness Scale , Digital Symbol Substitution Test, Trail Making Test Part A and B, Psychomotor Vigilance Test, and Simple Reaction Time test will also be administered to participants at baseline (prior to study drug consumption) and following completion of the driving simulation test. The entire protocol will be completed in one day and should take 4-4.5 hours to complete for each participant.

Cannabis sativa is one of the most ancient psychotropic drugs known to humanity. Although most Western countries have outlawed the use of cannabis according to the UN Convention of Psychotropic Substances, an increasing number of states in the USA, Canada and several European countries allow the medicinal use of cannabis subject to a doctor's recommendation. In oncology, the beneficial effects of treatment with the plant or treatment with medicine produced from its components are related to symptoms of the disease: pain, nausea and vomiting, loss of appetite and weight loss. There is only partial clinical evidence of the efficacy of cannabis for these indications. In Israel, according to Ministry of Health regulations, permission to use medicinal cannabis for oncology patients can be given for two indications: to relieve disease-related symptoms in advanced disease or during chemotherapy treatment to reduce side effects. The indications are very wide and allow a great deal of freedom for the physician's decisions, but also cause high demands for cannabis from patients. The cannabis plant and the synthetic drugs based on the plant are considered to be medically safe. Most of the adverse effects are related to the fact that the plant and the drugs are psychoactive. Among the effects named were dizziness, euphoria, difficulty concentrating, disturbances in thinking, memory loss, and loss of coordination. Recently, we published the results of a prospective, observational study evaluating the medical necessity for medicinal cannabis treatment in cancer patients on supportive or palliative care. No significant side effects, except for memory lessening in patients with prolonged cannabis use (p=0.002), were noted. Chemotherapy-related cognitive impairment (CRCI) is a phenomenon of cognitive decline that patients may experience during or after chemotherapy. Memory loss and lack of concentration and attention are the most frequent symptoms encountered. Evidence suggests that CRCI is of significant concern to patients and has become a major quality-of-life issue for survivors, with estimates of its frequency ranging from 14-85% of patients. The influence of cannabis use on cognitive functions of oncology patients has never been tested. Theoretically, the combination of chemotherapy and cannabis can cause severe reduction in cognitive functions in additive or synergistic ways. However, this hypothesis, too, has never been tested, although the number of patients using cannabis during chemotherapy treatments in Israel and in other Western countries is growing. Goals of current research: The main goal of the study is to evaluate prospectively the level of reduction in cognitive function of cancer patients who are on active oncology treatments and use cannabis, comparing to a group of patients without cannabis treatment. The second goal is to identify high-risk groups for cognitive impairment due to cannabis use. Patients and Methods: The study will be comprised of a cannabis user group that will include patients who will come for guidance sessions before being issued with a cannabis license and a control group of patients on active oncology treatments, meeting the same inclusion and exclusion criteria (except for cannabis use), and willing to complete the same pack of questionnaires and cognitive tests at the same three time points. All patients will sign an informed consent form. The study includes questionnaires on quality of life (EORTC-Q30), anxiety, depression (HADS) and fatigue (BFI), and cognitive tests (MoCA, DSST, Digital Finger Tapping) administered by the nurses who give guidance on cannabis according to the patient's language (Hebrew, Russian or Arabic). The nurses will have a short guidance course on "how to do cognitive tests" and a monthly meeting with a neuropsychologist to test the quality of the cognitive tests. The questionnaires and cognitive tests will be done on the day of entering the study (T0) and after 3 (T3) and 6 months (T6). The patients will be asked not to use cannabis in the 12 hours before the interviews after 3 and 6 months. Sample size: The sample size was built to show a difference of 1.1 points in the MoCA test (half the SD for the normal population) between two groups after three months of cannabis use. The number of patients needed with a power of 80%, β≤0.05 and SD=3.1 (the SD for mild cognitive impairment in the MoCA test) is calculated at 42 patients in each group (total 84 patients). Due to an expected drop-out of 20%, the number of patients to be included in the study is 101.

This is a single center, double-blind, placebo and positive-controlled, randomized, partial 6-way cross-over study to investigate the pharmacodynamics and pharmacokinetics of CEP-26401 (5, 25, and 125 μg) following single-dose administration to healthy male and female subjects.

Many volunteers visiting seniors make socially-based "friendly visits". This study investigated the efficacy of volunteers making visits focused on stimulating cognition. Participants were randomly assigned to either a "friendly visit" control group or a cognitive stimulation group. Seniors receiving stimulation visits made statistically significant improvement in memory abilities.

Constituents of grapes have been studied for their antioxidant, anti-inflammatory, and anticarcinogenic properties. In the past decade, there has been emerging evidence regarding a potential role for grapes in slowing cognitive decline and other effects of aging. Furthermore, evidence has been obtained in vivo that supplementation of aged rats with grape seed extract improves cognitive performance. Despite the promising accumulating data supporting the use of grapes as a safe and effective strategy for delaying the incidence of dementia, it remains unclear how grape intake would be useful with respect to factors such as dose schedule or stage of dementing illness. In general, well-controlled experimental data obtained in human subjects is in need of much further development. The investigators aim to measure effects of grape intake on cerebral metabolism and cognitive function, and to determine whether initial patterns, and magnitude of change, of cerebral metabolism assessed by positron emission tomography (PET) can serve respectively as a predictor of, and biomarker for, the magnitude of cognitive changes resulting from intake of grapes.

The objective of this study is to evaluate the effect of ginkgo biloba (steady state) on the pharmacokinetics of a single dose of the UGT-substrate raltegravir. Furthermore the safety profile of the combination is studied.

Mild Cognitive Impairment (MCI) is often an early manifestation of Alzheimer's disease (AD). The ability to identify MCI has led to hope that health prevention models might work in AD as they have in cancer and heart disease. Interventions which help sustain functioning in MCI may delay progression to a clinical AD diagnosis. To date, interventions aimed at maintaining functioning in MCI have been pharmacologic in nature. The efficacy of these medications in MCI is controversial, and those with MCI are also often interested in other activities they can do to manage their memory loss. When an individual is noted to have memory difficulties or MCI, a recommendation is often given for the patient to begin taking notes/using a calendar to help with memory or do cognitively stimulating activities. However, there is currently little instruction about how/what specific activities one should do and how effective they may be. The overall goal of this pilot project is to refine delivery of the Memory Support System (MSS)as a formal compensatory program for memory loss in MCI. Enrollment and retention data will be carefully investigated across 6 week and 10 day intervention groups. The investigators will compare participant adherence to the notebook training in the 6 week and 10 day versions of the intervention to the computer activity group. The investigators will also collect data on the clinical efficacy of the notebook and computer training to investigate if these interventions can sustain/improve functional level. Long term goals for this project also include delaying relocation for persons with MCI who may progress to dementia, thus not only improving the lives of these individuals, but also reducing health care expenditures. The investigators will recruit a total of 60 individuals with MCI and their 60 program partners across all three sites for this project. At least 16 of these pairs will be recruited at Emory University (maximum of 20 pairs/40 individuals anticipated). The investigators will randomly assign participants to the 6 week notebook or computer training or 10 day notebook or computer training. All participants will also receive patient education regarding MCI and cognitive health. Subsequent compliance with the MSS will be examined at 3 months, 6 months, and then annually following the intervention. Outcome measures will provide a detailed, multi-modal assessment of participants' functional level, overall cognitive functioning, mood, and self-efficacy, as well as caregiver burden and mood.

Marijuana use, for both recreational and therapeutic purposes, is becoming increasingly common as states remove restrictions on use. The increased use raises new concern about the safety of this drug, including its ability to impair basic cognitive and psychomotor tasks, and whether the users are aware of their impairment. We propose to design a simple performance test that users can use in the field, using a cell phone, to assess their level of impairment relative to their own drug-free state. In this preliminary study, we will compare participants' simple task performance after a known dose of delta-9-tetrahydrocannabinol (THC), or placebo, administered under double-blind conditions. In our app the participants will be asked to gauge their own perceived level of impairment (as determined by self-ratings and judgments of impairment) as well as their actual impairment (as gauged by the app), providing important feedback and training about their ability to detect impairment.

This multicentre randomized controlled trial aims to evaluate the effects of an intervention consisting of a TV-based Assistive Integrated Service developed to improve the quality of life in older people with mild cognitive impairment or mild dementia (PMCI/MD) and their informal caregivers. This study is a collaboration between four European countries (Spain, Romania, Italy and Switzerland) and the clinical trials will be conducted in two of these countries (Spain and Romania) In total 240 dyads, consisting of a person with mild cognitive impairment or mild dementia and their informal caregiver will be recruited for this study. Participant dyads will be randomized in a 1:1 ratio in two parallel groups: to receive either usual care from primary or specialized providers (control group) or to receive usual care plus access to a device with the Tv-AssistDem platform (intervention group). Participants in the trial will be assessed for a period of 12 months. After the baseline visit, all participants will have follow-up visits every 6 months together with a checkup of the PMCI/MD capacity to remain in the study. In the follow up visits, investigators will assess the PMCI/MD quality of life, caregiver's quality of life and burden, patient treatment adherence, patient functional status and service utilization. A user-behaviour analysis and usability evaluation will also be performed.

The Healthy Patterns Study intervention is a home-based activity intervention designed to improve symptoms of circadian rhythm disorders (CRD) and quality of life (QOL) in home-dwelling persons with dementia. We will use a randomized two-group parallel design of 200 people with dementia and their caregivers assigned to intervention or attention control groups.