Clinical trials: Agitation in Dementia
Alzheimer's Disease
Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease
The primary purpose of this study is to determine whether ELND005 is effective in treating symptoms of agitation and aggression in patients with Alzheimer's disease
- Trial name
- NCT01735630
- Testing
- ELND005
- Where
- 70 sites in United States, Canada and 2 more
- Volunteers
- 350 people
- Sponsor
- OPKO Health, Inc.
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
Agitation in Patients With Dementia of the Alzheimer's Type
Assessment of 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
- NCT04408755
- Testing
- AVP-786
- Where
- 95 sites in United States, Bulgaria and 9 more
- Volunteers
- 184 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Agitation,Psychomotor, Disruptive Behavior
A Medical Cannabis Oil for Treatment of Agitation and Disruptive Behaviors in Subjects With Dementia.
This double-blind, placebo-controlled study is designed to assess the effectiveness of, MediCane's medical cannabis oil extracted from MediCane's proprietary strain into GMP-grade olive oil, as an add-on therapy to standard of…
- Conditions
- Agitation,Psychomotor, Disruptive Behavior, Dementia, Alzheimer Disease
- Trial name
- NCT06217146
- Testing
- Medical Cannabis
- Where
- 3 sites in Israel
- Volunteers
- 24 people
- Sponsor
- M. H MediCane Ltd.
Alzheimer's Disease
A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
Active treatment extension study of the 331-14-213 trial, to assess the long-term safety and tolerability of oral brexpiprazole as treatment in adult participants with agitation associated with dementia of the Alzheimer's type…
- Trial name
- NCT03594123
- Testing
- Brexpiprazole
- Where
- United States
- Volunteers
- 259 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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
Memesto Wearable Device for Persons With Dementia
An estimated 70% of the 7.2+ million people in the U.S. with Alzheimer's Disease and Alzheimer's Disease-Related Dementias experience agitation, characterized by poorly organized and purposeless psychomotor activity that…
- Trial name
- NCT05153161
- Testing
- Memesto
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Edgewater Safety Systems, Inc.
Agitation in Dementia, Including Alzheimer's Disease
ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease
This is a randomized, double-blind, placebo-controlled study comparing the efficacy and safety of ITI-007 versus placebo administered orally once daily in the treatment of agitation in patients with dementia, including…
- Trial name
- NCT02817906
- Testing
- ITI-007
- Where
- 26 sites in United States
- Volunteers
- 177 people
- Sponsor
- Intra-Cellular Therapies, Inc.
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
Alzheimer's Disease
A 36-Week Safety Extension Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease
To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure, in Moderate to Severe AD patients with agitation and aggression.
- Trial name
- NCT01766336
- Testing
- Group 1 ELND005, Group 2 ELND005
- Where
- 46 sites in United States, Canada and 2 more
- Volunteers
- 296 people
- Sponsor
- OPKO Health, Inc.
Agitation in Adolescents and Young Adults With ASD
INP105 Proof-of-concept Study for the Acute Treatment of Agitation in Adolescents and Young Adults With ASD
This is a Phase 2a, proof-of concept, 2-way, 2-period crossover, double-blind study to evaluate the safety and efficacy of INP105 as an acute treatment versus placebo in adolescents and young adults with autism spectrum disorder…
- Trial name
- CALM 201 (NCT05163717)
- Testing
- INP105
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- Impel Pharmaceuticals
Alzheimer's Disease
Treatment for Aggression and Agitation in Patients With Alzheimer's Disease
The purpose of this study is to determine whether this drug can help symptoms of aggression and agitation in participants with Alzheimer's disease.
- Trial name
- NCT00843518
- Testing
- LY451395
- Where
- 17 sites in United States
- Volunteers
- 132 people
- Sponsor
- Eli Lilly and Company
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 and Aggression in Alzheimer's Disease
Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease (SERENE)
To evaluate the efficacy of pimavanserin compared with placebo in treatment of agitation and aggression after 12 weeks of treatment
- Trial name
- NCT02992132
- Testing
- Pimavanserin 34 mg, Pimavanserin 20 mg
- Where
- 56 sites in United States, Chile and 3 more
- Volunteers
- 111 people
- Sponsor
- ACADIA Pharmaceuticals 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.
Agitation, Delirium
Study of BXCL501 In Agitation Associated With Delirium in ICU Patients
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.
- Trial name
- NCT05313386
- Testing
- BXCL501
- Where
- United States
- Sponsor
- BioXcel Therapeutics Inc
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, Schizophrenia
Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia
This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in schizophrenia.
- Conditions
- Agitation, Schizophrenia, Schizo Affective Disorder, Schizoaffective Disorder
- Trial name
- SERENITY I (NCT04268303)
- Testing
- Sublingual film containing dexmedetomidine (BXCL501)
- Where
- 15 sites in United States
- Volunteers
- 380 people
- Sponsor
- BioXcel Therapeutics Inc
Agitation, Schizophrenia
Sub-Lingual Dexmedetomidine in Agitation Associated With Schizophrenia
This is a two-stage adaptive Phase Ib trial design, that will identify two doses (lowest dose with clinical benefit and highest safe dose) in a first stage and better evaluate safety, tolerability and variability of effect in the…
- Trial name
- NCT04010305
- Testing
- Sublingual film containing BXCL501 (Dexmedetomidine)
- Where
- 12 sites in United States
- Volunteers
- 135 people
- Sponsor
- BioXcel Therapeutics 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