Clinical trials: Psychomotor Agitation
Agitation Associated With, Alzheimer's Disease
A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole in the Treatment of Alzheimer's Agitation
To compare the efficacy of 2 fixed doses of brexpiprazole with placebo in participants with agitation associated with dementia of the Alzheimer's type.
- Conditions
- Agitation Associated With, Alzheimer's Disease, Alzheimer's Type, Mental Disorder
- Trial name
- NCT01862640
- Testing
- Brexpiprazole, OPC-34712
- Where
- 85 sites in United States, Croatia and 5 more
- Volunteers
- 433 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Alzheimer's Disease
Efficacy of ORM-12741 on Agitation/Aggression Symptoms in Alzheimer's Disease
This study evaluates the effect of ORM-12741 on agitation/aggression symptoms in Alzheimer's disease. Two thirds of the patients will receive ORM-12741 and one third will receive placebo.
- Trial name
- Nebula (NCT02471196)
- Testing
- ORM-12741
- Where
- Finland
- Volunteers
- 308 people
- Sponsor
- Orion Corporation, Orion Pharma
Acute Agitation
Safety and Tolerability of INP105 (Olanzapine by I231 POD® Device) Nasal Spray in Healthy Volunteers - SNAP 101
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of INP105, which is an investigational drug-device combination product comprised of the drug component OLZ administered by a…
- Trial name
- SNAP101 (NCT03624322)
- Testing
- Zyprexa IM, Zydis, INP105
- Where
- Australia
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Impel Pharmaceuticals
Agitation Associated With Dementia of the Alzheimer's Type
Brexpiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
To evaluate the superiority of brexpiprazole 1 mg or 2 mg over placebo after a 10-week treatment regimen for agitation associated with dementia of the Alzheimer's type in patients who require medication, and to investigate the…
- Trial name
- NCT03620981
- Testing
- Brexpiprazole
- Where
- Japan
- Volunteers
- 410 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Agitation Associated With Alzheimer's Disease, Alzheimer's Type
Safety Follow-up Study for Subjects With Agitation Associated With Dementia of the Alzheimer's Type Who Previously Participated in a Double-blind Trial of Brexpiprazole or Placebo
To follow-up on the safety of subjects who were previously treated in a double-blind trial of brexpiprazole.
- Conditions
- Agitation Associated With Alzheimer's Disease, Alzheimer's Type, Mental Disorder, Nervous System Diseases
- Trial name
- NCT02192554
- Where
- 84 sites in United States, Bulgaria and 10 more
- Volunteers
- 450 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
IM and Oral in Acute Exacerbation of Schizophrenia (BIZET Study)
To evaluate efficacy and tolerability of Ziprasidone IM and oral in agitated patients with acute exacerbation of schizophrenia
- Trial name
- NCT00136994
- Testing
- Ziprasidone
- Where
- 34 sites in Italy
- Volunteers
- 160 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Alzheimer Disease, Agitation,Psychomotor
Clinical Trial on Agitation in Alzheimer's Dementia
The purpose of this study is to assess the efficacy of the oral medication IGC-AD1, a THC-based (Delta-9-Tetrahydrocannabinol) formulation administered twice a day on Agitation in patients with mild to severe dementia from…
- Conditions
- Alzheimer Disease, Agitation,Psychomotor, Care Giving Burden, NPS
- Trial name
- CALMA (NCT05543681)
- Testing
- IGC-AD1-Active
- Where
- 28 sites in United States, Canada and 1 more
- Volunteers
- 164 people
- Sponsor
- IGC Pharma, LLC
Agitation Associated With Alzheimer's Disease Dementia
Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia
The goal of this clinical trial is to evaluate the safety and efficacy of EXV-802 and EXV-801 in treatment of agitation in participants with Alzheimer's Disease dementia.
- Trial name
- SERENADA (NCT07284472)
- Testing
- EXV-802, EXV-801
- Where
- 49 sites in United States, Canada and 7 more
- Volunteers
- 300 people
- Sponsor
- Exciva GmbH
Alzheimer Disease, Agitation
A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)
The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in…
- Trial name
- NCT06937229
- Testing
- KarXT, KarX-EC
- Where
- 252 sites in United States, Argentina and 24 more
- Volunteers
- 650 people
- Sponsor
- Bristol-Myers Squibb
Alzheimer's Disease
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.
- Trial name
- NCT07011745
- Testing
- Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule
- Where
- 143 sites in United States, Argentina and 12 more
- Volunteers
- 426 people
- Sponsor
- Bristol-Myers Squibb
Alzheimer's Disease
An Evaluation of the Safety and Efficacy of Memantine in Agitated Patients With Moderate to Severe Alzheimer's Disease
About 65% of patients with severe Alzheimer's Disease (AD) will have symptoms of agitation. There are drawbacks associated with the currently available therapeutic interventions for agitation associated with Alzheimer's Disease.
- Trial name
- NCT00097916
- Testing
- memantine HCl
- Where
- 9 sites in United States
- Volunteers
- 34 people
- Sponsor
- Forest Laboratories
Agitation Associated With Alzheimer's Dementia
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia
This is a multicenter, randomized, double-blind, placebo-controlled, flexible-dose study of the efficacy, safety, and tolerability of ITI-1284 in patients with agitation associated with Alzheimer's dementia.
- Trial name
- NCT06651567
- Testing
- ITI-1284
- Where
- 70 sites in United States, Bulgaria and 6 more
- Volunteers
- 320 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease
A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation
This study will evaluate the long-term safety and efficacy of AXS-05 in subjects with Alzheimer's disease (AD) agitation.
- Conditions
- Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation, Psychomotor
- Trial name
- ACCORD-2 (NCT04947553)
- Testing
- AXS-05 (dextromethorphan-bupropion)
- Where
- 47 sites in United States, Canada and 1 more
- Volunteers
- 456 people
- Sponsor
- Axsome Therapeutics, Inc.
Agitation, Alzheimer Disease
Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease
This is a study to evaluate the efficacy, safety, and tolerability of BMS-986368, a FAAH/MAGL inhibitor, for the treatment of agitation in participants with Alzheimer's Disease.
- Trial name
- NCT06808984
- Testing
- BMS-986368
- Where
- 77 sites in United States, Argentina and 2 more
- Volunteers
- 120 people
- Sponsor
- Celgene
Agitation, Dementia
An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia
A randomized, double-blind, placebo-controlled parallel group 3-arm study assessing efficacy, safety, and tolerability of two doses BXCL501 in male and female geriatric residents (65 years and older) with acute agitation…
- Trial name
- NCT05276830
- Testing
- BXCL501
- Where
- 3 sites in United States
- Volunteers
- 5 people
- Sponsor
- BioXcel Therapeutics Inc
Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation
This trial was 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.
- Conditions
- Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation
- Trial name
- ADVANCE-2 (NCT05557409)
- Testing
- AXS-05
- Where
- 55 sites in United States, Puerto Rico
- Volunteers
- 408 people
- Sponsor
- Axsome Therapeutics, Inc.
Agitation in Patients With Dementia of the Alzheimer's Type
Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
This study was conducted to evaluate the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) compared to placebo for the treatment of agitation in participants with…
- Trial name
- NCT04464564
- Testing
- AVP-786
- Where
- 106 sites in United States, Belgium and 11 more
- Volunteers
- 241 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Agitation Associated With Dementia of the Alzheimer's Type
Brexpiprazole for the Long-term Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
To evaluate the safety of brexpiprazole 1 mg or 2 mg after a 14 week treatment regimen for agitation associated with dementia of the Alzheimer's type patients who completed in a double-blind trial, and to investigate the efficacy…
- Trial name
- NCT03724942
- Testing
- Brexpiprazole
- Where
- Japan
- Volunteers
- 164 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Alzheimer's Disease
Memesto Wearable Repetitive Message and Music Therapy Device Music Therapy Device That Senses and Reduces Agitation in People With AD,
This is a 12-week proof-of-concept study to evaluate the efficacy of Memesto in reducing agitation in persons with Alzheimer's disease and Alzheimer's disease related dementias (AD/ADRD) currently living in a residential care…
- Trial name
- AWARD (NCT06596278)
- Testing
- Memesto
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Edgewater Safety Systems, Inc.
Agitation in Dementia
To Evaluate the Efficacy, Safety, and Tolerability of Dronabinol Oral Solution for Agitation in Patients With Alzheimer's Disease
This study tests a medication called dronabinol in people with Alzheimer's disease. First, participants go through up to 4 weeks of screening. Then, over 2 weeks, the dose of the study drug is slowly increased.
- Trial name
- NCT07422311
- Testing
- Dronabinol Oral Solution
- Where
- Australia
- Volunteers
- 140 people
- Sponsor
- Benuvia Therapeutics Inc.