11 Chuen On Road Tai Po, Hong Kong
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Diverse VCID "Vascular Cognitive Impairment and Dementia"
The study will require 3 visits: • A baseline visit, plus 2 subsequent annual follow-up visits over 3 years • The follow-up visits may be spaced up to 18 months apart. Participation in this study will involve completing physical, neurological, and cognitive examinations sufficient to complete the Alzheimer’s Disease Program Uniform Data Set (UDS), blood draws, and a brain MRI at baseline, and at annual follow-up visits 2 and 3. The de-identified data collected from the study will be shared with members of the Diverse VCID Consortium and other collaborating researchers for the study of vascular health and other conditions (e.g., Alzheimer’s disease, other forms of dementia, mental illness, HIV/AIDS, cancer, heart disease, and others). Recruitment into the study ends in March of 2024 and the final study will be concluded August 30, 2027.
Phase
4Span
232 weeksSponsor
National Institute of Neurological Disorders (NINDS) and Stroke/National Institutes of HealthNew York, New York
Recruiting
Healthy Volunteers
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Cognitive Reappraisal Training for Borderline Personality (BPD)
Borderline Personality Disorder (BPD) is a prevalent, enduring and disabling psychiatric condition found in approximately 2% to 5.9% of the population and 20% of hospitalized psychiatric patients. Suicide rates of approximately 10% have been reported. One of the most prominent clinical features of BPD is extreme mood shifts occurring in response to external social/emotional events. The emotional instability in BPD contributes to many of the most disabling, even life-threatening, symptoms of the disorder, including suicidality, outbursts of intense anger, and seriously impaired role functioning. The severity of the BPD symptom profile, its prevalence, chronicity and high burden upon health care services make the development of effective and accessible treatment for BPD a high priority. Yet there is no current medication treatment indicated for BPD and the psychotherapies recognized for the disorder have been shown to have small effect sizes and are of limited availability. The present study builds upon work by the group that has shown that deficiencies in the ability to regulate emotion by engaging typically adaptive cognitive strategies (cognitive reappraisal, CR) and to effectively activate associated neural systems can be corrected by focused training in CR. The R61 phase of this study examines a manualized intensive training program in CR, tests that it effects target neural systems implicated in emotional processing and enhances behavioral reappraisal success. It examines 2-, 4- and 6- weeks of twice a week treatment to identify the optimal dose. Measures include fMRI imaging and clinical ratings at baseline and each of these subsequent time points. Upon demonstrating that CR training is superior to a control condition in enhancing performance in the neural target at one or more of these dose durations, the researchers will proceed to the R33 phase. In the R33 phase, the researchers will treat a larger sample of BPD patients at the optimal 6-week dose defined in the R61 phase to 1) demonstrate reproducibility of the R61 findings, 2) to demonstrate that CR training is superior to control in improving BPD clinical outcomes at the end of treatment and at 1- and 4- month follow-up, and 3) that change in activity at the neural targets is associated with clinical improvement. The results of this study can support the introduction of CR training as a new psychosocial approach for the treatment of BPD, either as stand-alone treatment or as an augmenting strategy. It may, moreover, have application to a range of psychiatric disorders characterized by severe emotional instability.
Phase
N/ASpan
142 weeksSponsor
Icahn School of Medicine at Mount SinaiNew York, New York
Recruiting
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Phase 1/2 Study Of Intratumoral G100 With Or Without Pembrolizumab or Rituximab In Patients With Follicular Non-Hodgkin’s Lymphoma
See CT.gov: **[**www.clinicaltrials.gov/ct2/show/NCT02501473**](https://www.clinicaltrials.gov/ct2/show/NCT02501473?term=G142&rank=1)**
Phase
1/2Span
Sponsor
New York, New York
Recruiting
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Study of HB-200 alone and with pembrolizumab for patients with Recurrent/ Metastatic HPV 16+ Head and Neck and other Cancers
Phase
1/2Span
Sponsor
Hookipa BiotechNew York, New York
Recruiting
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Methodology Issues in a Tailored Light Treatment for Persons With Dementia
In a within subjects, randomized placebo control study, a tailored light treatment will be used for short-term (4 weeks). Outcome measures include sleep measures (actigraphy), and questionnaires probing behavior and mood in those who have been diagnosed with Alzheimer's disease and related dementia. After a 4-week washout period, a placebo control inactive light will be used for another 4 weeks.
Phase
N/ASpan
313 weeksSponsor
Icahn School of Medicine at Mount SinaiNew York, New York
Recruiting
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ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease
The study is designed to evaluate safety and efficacy of ATH-1017 in mild to moderate AD subjects, with randomized, parallel-arm treatment duration of 26 weeks, and based on clinical diagnostic criteria of Alzheimer's disease. Clinical efficacy is demonstrated by improvement in cognition and global/functional assessments comparing treatment to placebo.
Phase
2/3Span
203 weeksSponsor
Athira PharmaNew York, New York
Recruiting
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Methodology Issues in a Tailored Light Treatment for Persons With Dementia - Aim 2
Phase
N/ASpan
147 weeksSponsor
Icahn School of Medicine at Mount SinaiNew York, New York
Recruiting
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Single-dose Ketamine Treatment to Improve Depression in Mild Cognitive Impairment
Ketamine is a rapid-acting antidepressant thought to work, at least in part, by the enhancement of neural plasticity and the growth of new synapses. A single dose of ketamine has been shown to improve depression and cognition with short-term memory, inhibitory control, cognitive flexibility, and processing speed showing improvements within days of treatment. The mechanism behind ketamine’s rapid action is not clear but some groups have speculated it may be related to enhanced neuroplasticity, particularly in the frontal areas and the hippocampus. If this mechanism is accurate, ketamine may be especially effective in treating individuals with mild cognitive impairment and depression (MCI-D) where changes in the hippocampus and frontal areas have been implicated. Although few studies have been published on the effects of ketamine in older adults, they suggest that ketamine treatment might be effective in improving depression in older adults and relatively safe. There are no studies looking at the effects of ketamine treatment in patients with MCI-D. A key hypothesis of this study is that IV ketamine treatment will be well-tolerated and will improve depression and cognition in patients with MCI-D. The effects of brain imaging and activity abnormalities and amyloid biomarker status on the responsiveness to ketamine will be explored. This open-label pilot study is designed to gather data to support an application for a larger NIH-funded study. This study is an open-label trial to determine the safety and tolerability of a single sub-anesthetic (0.5 mg/kg) intravenous (IV) ketamine treatment in individuals with mild cognitive impairment and depression (MCI-D). As secondary endpoints, whether treatment with a single dose of ketamine may improve mood or cognition in individuals with MCI-D will be examined. In exploratory analyses, whether AD biomarker status has any influence on the effectiveness of ketamine treatment in MCI and brain connectivity changes after ketamine treatment will be examined. The entire study period will be approximately 1 month from start to finish. The study begins with screening followed by a baseline visit. Then there will be a single visit where an infusion of 0.5 mg/kg of IV ketamine will be performed. There will be follow- up visits 1 day, 2 days, 3 days, 7 days, and one month after the infusion. Baseline visit will include questionnaires, blood draw, cognitive evaluation, clinical evaluation, neuroimaging (specifically a non-contrast magnetic resonance image (MRI)), and an optional electroencephalogram (EEG). Follow-ups will include questionnaires, cognitive evaluation, and clinical evaluation. Additionally, blood draw and imaging (MRI) follow-up may be performed.
Phase
2Span
115 weeksSponsor
Icahn School of Medicine at Mount SinaiNew York, New York
Recruiting
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Music Experiences in Patients with Mild Cognitive Impairment (MCI) and Alzheimer’s Disease (AD)
Answering questions over the phone, maintaining contact with study staff via Zoom or other remote platform at regular intervals
Phase
N/ASpan
Sponsor
New York City, New York
Recruiting
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New York, New York
Recruiting