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Agitation clinical trials

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NCT ID: NCT06140342 Recruiting - Dementia Clinical Trials

A Music-Based Mobile App for People Living With Alzheimer's Disease and Related Dementias (ADRD)

Start date: August 1, 2023
Phase:
Study type: Observational

The purpose of this pilot is to develop a mobile application that detects physiological measures of individuals with Alzheimer's disease and related dementias and triggers auto-play of personalized songs in a wearable device. The investigators will test the feasibility and acceptability of the app. This app may be an important tool to include in daily caregiving in a home setting by extending established benefits of music therapy for people with Alzheimer's disease and related dementias.

NCT ID: NCT06052254 Not yet recruiting - Agitation Clinical Trials

Dexmedetomidine Transdermal Systems (DMTS) Treatment for Agitation Associated With Dementia of the Alzheimer's Type

Start date: December 2023
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of DMTS on frequency and severity of agitation associated with dementia of the Alzheimer's type, compared with placebo.

NCT ID: NCT06037629 Recruiting - Acute Pain Clinical Trials

Premature Enhanced Automated Capture of Comfort Knowledge

PEACOCK
Start date: February 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to develop methods that could provide continual monitoring of comfort levels for preterm neonates in hospitals.

NCT ID: NCT05974527 Not yet recruiting - Schizophrenia Clinical Trials

Pilot Study 1: Efficacy and Safety of Sublingual Dexmedetomidine (BXCL501) for the Treatment of Agitation in the Emergency Department

Start date: September 1, 2023
Phase: Phase 4
Study type: Interventional

This is a single-arm pilot study to examine the impact of BXCL501 (sublingual film formulation of dexmedetomidine) administration on reducing the severity of undifferentiated acute agitation in patients presenting to the emergency department with underlying bipolar disorder or schizophrenia. This study is designed to evaluate BXCL501 for its FDA-approved indication -- treatment of agitation associated with bipolar disorder or schizophrenia -- applied in the emergency department setting.

NCT ID: NCT05665088 Terminated - Dementia Clinical Trials

Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III)

Start date: December 14, 2022
Phase: Phase 3
Study type: Interventional

A study to determine the safety and efficacy of BXCL501 dosing for episodes of agitation associated with dementia when they occur (given as needed [PRN]), for a maximum of 168 doses within a 12-week treatment period.

NCT ID: NCT05644262 Recruiting - Dementia Clinical Trials

Life's End Benefits of Cannabidiol and Tetrahydrocannabinol

LiBBY
Start date: December 18, 2023
Phase: Phase 2
Study type: Interventional

This is a multicenter randomized double-blind placebo-controlled Phase 2 study of an oral combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) compared to placebo over 12 weeks. This study is designed to test the hypothesis that treatment with an oral combination of THC/CBD will reduce agitation hospice care-eligible patients with agitation and dementia as measured by the Cohen Mansfield Agitation Inventory (CMAI) when compared to placebo at 2 weeks. This study will enroll approximately 150 participants of any gender at least 40 years of age who are hospice care-eligible with agitation and dementia (HAD). Participants will be randomized (50:50) to either active study drug (T2:C100) or placebo. The double-blind period of this study is 12 weeks. A 24 week optional open-label extension will be offered to participants who complete the double-period.

NCT ID: NCT05557409 Recruiting - Alzheimer Disease Clinical Trials

A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation

ADVANCE-2
Start date: September 6, 2022
Phase: Phase 3
Study type: Interventional

This trial is a multi-center, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of AXS-05 compared to placebo for the treatment of agitation associated with Alzheimer's disease.

NCT ID: NCT05522647 Not yet recruiting - Agitation Clinical Trials

Detection of Risk Behaviors: Pilot Observational Study With Bedridden and Agitated Patients.

DECORIPAA
Start date: September 1, 2022
Phase:
Study type: Observational

There is a risk of falls and injuries in bedridden hospitalized patients, increased in agitated or confused patients. In neurosurgery departments, brain damaged patients can present a loss of consciousness of risky behaviors and be in a state of agitation which frequently leads to their endangerment. The repercussions of this endangerment are multiple. For the patients, there may be a feeling of insecurity, with physical or chemical restraint solutions which deprive them of their freedom without a total guarantee of safety. For the caregivers, there is an emotional distress in front of this endangerment, and a professional guilt. Finally, there are economic repercussions due to the costs of complementary examinations and the lengthening of hospitalization. The objective of the present study is to determine the nature and frequency of occurrence of risk behaviours, through the observation of bedridden and agitated hospitalized patients. These risk behaviours are defined as potentially dangerous and are warning signs for the caregiver. A better understanding of these behaviours could help to better anticipate falls and injuries and to implement preventive measures more quickly.

NCT ID: NCT05397639 Recruiting - Agitation Clinical Trials

Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type

Start date: November 1, 2022
Phase: Phase 3
Study type: Interventional

This study will be conducted to evaluate the efficacy, safety, tolerability, and pharmacokinetics of masupirdine compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type.

NCT ID: NCT05313386 Withdrawn - Delirium Clinical Trials

Study of BXCL501 In Agitation Associated With Delirium in ICU Patients

Start date: February 23, 2021
Phase: Phase 2
Study type: Interventional

This study is designed to determine and evaluate the optimal BXCL501 starting dose (StartD) that will safely and effectively reduce agitation associated with delirium in ICU patients. This is an ascending adaptive dose study evaluating the safety and efficacy of four potential starting doses of BXCL501 (120 μg, 180 μg, 240 μg, and 300 μg) in reducing agitation levels in adult ICU patients with delirium. For subjects 65 years of age and older, the potential doses will be reduced 50% in line with the Precedex (reference drug) label. The purpose of this clinical trial is to identify an optimally safe and effective BXCL501