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Clinical trials for Alzheimer Disease AND Agitation AND placebo

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44346   clinical trials with a EudraCT protocol, of which   7374   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    24 result(s) found for: Alzheimer Disease AND Agitation AND placebo. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2020-000798-26 Sponsor Protocol Number: 20-AVP-786-306 Start Date*: 2021-06-22
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q...
    Medical condition: Agitation in patients with dementia of the Alzheimer’s type
    Disease: Version SOC Term Classification Code Term Level
    21.1 10037175 - Psychiatric disorders 10001499 Agitation mental LLT
    20.0 10029205 - Nervous system disorders 10012271 Dementia Alzheimer's type PT
    20.0 10029205 - Nervous system disorders 10001896 Alzheimer's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) PT (Trial now transitioned) PL (Trial now transitioned) DK (Trial now transitioned) BG (Trial now transitioned) GR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-000799-39 Sponsor Protocol Number: 20-AVP-786-307 Start Date*: 2021-02-05
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q...
    Medical condition: Agitation in patients with dementia of the Alzheimer’s type
    Disease: Version SOC Term Classification Code Term Level
    21.1 10037175 - Psychiatric disorders 10001499 Agitation mental LLT
    20.0 10029205 - Nervous system disorders 10012271 Dementia Alzheimer's type PT
    20.0 10029205 - Nervous system disorders 10001896 Alzheimer's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Trial now transitioned) SK (Trial now transitioned) NL (Ongoing) SI (Trial now transitioned) HR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-000503-17 Sponsor Protocol Number: 331-12-284 Start Date*: 2015-01-29
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Flexible Dosing of Brexpiprazole (OPC-34712) in the Treatme...
    Medical condition: Agitation Associated with Dementia of the Alzheimer’s Type
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029205 - Nervous system disorders 10012271 Dementia Alzheimer's type PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) FI (Prematurely Ended) SI (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2013-000504-41 Sponsor Protocol Number: 331-12-283 Start Date*: 2013-12-10
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: Country-specific protocol amendment for Germany entitled: A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2...
    Medical condition: Agitation Associated with Dementia of the Alzheimer’s Type
    Disease: Version SOC Term Classification Code Term Level
    19.1 10029205 - Nervous system disorders 10012271 Dementia Alzheimer's type PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2016-001127-32 Sponsor Protocol Number: ACP-103-032 Start Date*: 2016-09-19
    Sponsor Name:ACADIA Pharmaceuticals Inc.
    Full Title: A Double-Blind, Placebo-Controlled Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer’s Disease
    Medical condition: Agitation and Aggression in Alzheimer’s Disease
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004852 10001896 Alzheimer's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-000217-30 Sponsor Protocol Number: 3098012 Start Date*: 2015-06-16
    Sponsor Name:Orion Corporation
    Full Title: EFFICACY OF ORM-12741 ON AGITATION/AGGRESSION SYMPTOMS IN PATIENTS WITH ALZHEIMER’S DISEASE: A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTICENTRE STUDY OF 12 WEEKS
    Medical condition: The agitation/aggression symptoms in patients with Alzheimer’s disease
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004852 10001896 Alzheimer's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) FI (Completed) PL (Completed) BG (Completed) RO (Suspended by CA) HR (Completed)
    Trial results: View results
    EudraCT Number: 2017-003940-19 Sponsor Protocol Number: 331-14-213 Start Date*: 2018-08-06
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3, 12-Week, Multicenter, Randomized, Double-blind, Placebo controlled, 2 Arm, Fixed-dose Trial to Evaluate the Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) in the Treatme...
    Medical condition: Agitation Associated With Dementia of the Alzheimer’s Type
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10012271 Dementia Alzheimer's type PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) ES (Ongoing) HU (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2021-003405-22 Sponsor Protocol Number: CTP3S1502HT6 Start Date*: 2022-09-02
    Sponsor Name:Suven Life Sciences Ltd.
    Full Title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Masupirdine (SUVN-502) for the Tre...
    Medical condition: Agitation with Dementia of the Alzheimer's Type
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10012271 Dementia Alzheimer's type PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Trial now transitioned) HR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2005-003475-20 Sponsor Protocol Number: S1543016 Start Date*: 2006-05-25
    Sponsor Name:Solvay Pharmaceuticals, Inc
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Efficacy, Safety and Tolerability Study of Bifeprunox in the Treatment of Elderly Subjects with Psychosis and Behavioural Disturbances Associated wit...
    Medical condition: Dementia of the Alzheimer's type (DSM-IV TR) code 294.11
    Disease: Version SOC Term Classification Code Term Level
    10012271
    Population Age: Elderly Gender: Male, Female
    Trial protocol: EE (Prematurely Ended) CZ (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-001339-38 Sponsor Protocol Number: 17-AVP-786-305 Start Date*: 2018-01-22
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-design study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/qui...
    Medical condition: Agitation Associated with Dementia of the Alzheimer's Type
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10001497 Agitation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) ES (Ongoing) FR (Completed) GB (GB - no longer in EU/EEA) CZ (Completed) BG (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-003269-17 Sponsor Protocol Number: 146-05-hsr-burn Start Date*: 2006-05-05
    Sponsor Name:manchester mental health and social care trust
    Full Title: Aromatherapy in Alzheimer's disease: a randomised controlled trial in comparison with Aricept
    Medical condition: This is a trial of Aricept versus placebo versus aromatherapy in people with Alzheimer's disease.
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2007-004918-14 Sponsor Protocol Number: A2501056 Start Date*: 2008-05-06
    Sponsor Name:Pfizer Inc, 235 East 42nd Street, New York,NY 10017
    Full Title: A 12-WEEK, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE IMPACT OF DONEPEZIL HYDROCHLORIDE (ARICEPT®) ON BEHAVIORAL AND PSYCHOLOGICAL SYMPTOMS IN PATIENTS WITH SEVERE ALZHEIMER’S DISEASE
    Medical condition: SEVERE ALZHEIMER’S DISEASE
    Disease: Version SOC Term Classification Code Term Level
    9.1 10001896 Alzheimer's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-004299-20 Sponsor Protocol Number: ELND005-AG201 Start Date*: 2013-04-25
    Sponsor Name:Transition Therapeutics Ireland Ltd
    Full Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Efficacy and Safety Study of Oral ELND005 for Treatment of Agitation and Aggression in Patients With Moderate to Severe Alzheime...
    Medical condition: Agitation and Aggression in Moderate to Severe Alzheimer’s Disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2017-004893-32 Sponsor Protocol Number: CL03-ORY-2001 Start Date*: 2018-04-03
    Sponsor Name:Oryzon Genomics S.A.
    Full Title: A multicentre, multinational, randomised, double-blind, placebo-controlled, 3-arm, 24-week parallel-group study to evaluate the safety, tolerability and preliminary efficacy of ORY-2001 in patients...
    Medical condition: Alzheimer Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10001896 Alzheimer's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) FR (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2022-001515-10 Sponsor Protocol Number: KAR-031 Start Date*: 2022-12-12
    Sponsor Name:Karuna Therapeutics
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Relapse Prevention Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated with Alzheimer’s Disease Deme...
    Medical condition: Psychosis Associated with Alzheimer’s Disease Dementia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10012271 Dementia Alzheimer's type PT
    20.0 100000004873 10037234 Psychosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) SK (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned) BG (Trial now transitioned) DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-001056-17 Sponsor Protocol Number: 3606 Start Date*: 2020-08-14
    Sponsor Name:Kings's College London [...]
    1. Kings's College London
    2. South London and Maudsley NHS Foundation Trust
    Full Title: A randomised feasibility trial investigating Sativex® for the treatment of the Agitation & Aggression (A/A) in Alzheimer’s Dementia.
    Medical condition: Clinically significant agitation in Alzheimer's Diseases
    Disease: Version SOC Term Classification Code Term Level
    21.1 10037175 - Psychiatric disorders 10001499 Agitation mental LLT
    20.0 10037175 - Psychiatric disorders 10001497 Agitation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2005-005087-93 Sponsor Protocol Number: Start Date*: 2006-11-17
    Sponsor Name:East Kent Hospitals NHS Trust
    Full Title: A randomized double blind placebo controlled trial of Memantine in the treatment of Agitation in Alzheimers Dementia
    Medical condition: Alzheimers dementia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-000424-23 Sponsor Protocol Number: 331-13-211 Start Date*: 2014-10-31
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A 2-month, Observational, Rollover Trial to Evaluate the Safety of Subjects with Agitation Associated with Dementia of the Alzheimer?s Type who were Previously Treated with Brexpiprazole (OPC-34712...
    Medical condition: Agitation Associated with Dementia of the Alzheimer's Type
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) SI (Completed) FR (Completed) GB (Completed) HR (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2010-020008-31 Sponsor Protocol Number: ACP-103-019 Start Date*: 2013-10-25
    Sponsor Name:ACADIA Pharmaceuticals Inc
    Full Title: A Single center, Double-Blind, Placebo-Controlled Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Psychosis in Alzheimer’s Disease
    Medical condition: Psychosis associated with Alzheimer's disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2019-002106-52 Sponsor Protocol Number: CANBiS-AD Start Date*: 2020-03-19
    Sponsor Name:King's College London [...]
    1. King's College London
    2. South London and Maudsley NHS Foundation Trust
    Full Title: CANnabidiol for Behavioural Symptoms in Alzheimer’s Disease
    Medical condition: Alzheimer's disease patients with BPSD
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10001896 Alzheimer's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
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