Clinical trials: Agitation in Dementia
Bipolar Disorder, Schizophrenia
Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder
This is an in-clinic, single arm, open-label study assessing tachyphylaxis, tolerance, and withdrawal following repeated doses of Igalmi in adult males and females with agitation associated with schizophrenia or bipolar disorder.
- Conditions
- Bipolar Disorder, Schizophrenia, Agitation,Psychomotor, Schizo Affective Disorder
- Trial name
- NCT06041646
- Testing
- Sublingual film containing Igalmi
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- BioXcel Therapeutics Inc
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
- 71 sites in United States, Bulgaria and 6 more
- Volunteers
- 320 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Agitation, Alzheimer's Disease
Efficacy, Safety and Tolerability Study of AVP-923 (Dextromethorphan/Quinidine) for Treatment of Symptoms of Agitation in Participants With Alzheimer's Disease
The objectives of the study are to evaluate the safety, tolerability and efficacy of AVP-923 compared to placebo, for the treatment of symptoms of agitation in participants with Alzheimer's Disease (AD).
- Trial name
- NCT01584440
- Testing
- AVP-923-20, AVP-923-30
- Where
- 44 sites in United States
- Volunteers
- 220 people
- Sponsor
- Avanir Pharmaceuticals
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 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 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 Patients With Dementia of the Alzheimer's Type
Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
This was an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305.
- Trial name
- NCT02446132
- Testing
- AVP-786
- Where
- 227 sites in United States, Bulgaria and 8 more
- Volunteers
- 1,197 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Dementia
Study of Depakote for Behavioral and Psychological Symptoms in Dementia
This prospective, naturalistic, open label study will test the hypothesis that Depakote is correlated with a reduction in elevated Cohen-Mansfield Agitation Index (CMAI) verbal and physical agitation and aggression scales over a…
- Trial name
- NCT00197834
- Testing
- Depakote
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Hearthstone Alzheimer Care
Agitation Associated With Alzheimer's Disease Dementia
A Study of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia
To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan.
- Trial name
- NCT06803823
- Testing
- ONO-2020
- Where
- 39 sites in Japan
- Volunteers
- 90 people
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Agitation
Phase IV to Evaluate the Safety of Self-administered ADASUVE® in Agitated Patients Outside the Hospital Setting
Phase IV, multinational, multicentre, open-label, non-randomized, clinical trial conducted in Europe (Spain, Germany, Finland, Norway, Romania and Austria) to evaluate the safety profile of ADASUVE® in agitated patients with…
- Trial name
- NCT02525991
- Testing
- Staccato® Delivery System Loxapine (ADASUVE®)
- Where
- Spain
- Volunteers
- 323 people
- Sponsor
- Ferrer Internacional S.A.
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
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 in Patients With Dementia of the Alzheimer's Type
Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.
- Trial name
- NCT03393520
- Testing
- AVP-786
- Where
- 211 sites in United States, Australia and 9 more
- Volunteers
- 601 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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 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.
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 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
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 and Aggression in Alzheimer's Disease
A Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects With Alzheimer's Disease
To evaluate the safety and tolerability of pimavanserin over 52 weeks of treatment in subjects with probable AD who have symptoms of agitation and aggression
- Trial name
- NCT03118947
- Testing
- Pimavanserin
- Where
- 28 sites in United States, Chile and 3 more
- Volunteers
- 79 people
- Sponsor
- ACADIA Pharmaceuticals Inc.
Agitation,Psychomotor, Dementia
Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia
This is an adaptive Phase 1b/2 trial design. It is randomized, double-blind, placebo-controlled, multiple ascending dose study assessing efficacy, pharmacokinetics, safety and tolerability of BXCL-501 dosing in adult (65 years…
- Trial name
- TRANQUILITY (NCT04251910)
- Testing
- Sublingual film containing Dexmedetomidine
- Where
- 5 sites in United States
- Volunteers
- 100 people
- Sponsor
- BioXcel Therapeutics Inc