Agitation and Aggression in Alzheimer's DiseasePhase 2NCT03118947
A Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects With Alzheimer's Disease
A Phase 2 study testing Pimavanserin in people with Agitation and Aggression in Alzheimer's Disease, run by ACADIA Pharmaceuticals Inc. at 28 sites in 5 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Agitation and Aggression in Alzheimer's Disease
- What is being tested?
- Pimavanserin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 28 sitesin 5 countries
- Study dates
- 23 Feb 2017to 25 Feb 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must complete the Week 12 visit in Study ACP-103-032 while continuing to take his/her assigned dose of blinded study drug
- Can understand the nature of the trial and protocol requirements and provide signed informed consent
- from patient, if deemed competent to provide consent
- from an appropriate person (e.g. patient's Legally Authorized Representative (LAR) with the patient's assent) if patient is deemed not competent to provide informed consent.
- Lives at home or in an assisted living or care facility (but has the capacity to visit the clinic as an outpatient)
- Has a designated study partner/caregiver who is in contact with the patient at least 3 times a week on 3 separate days
- Female patients must be of non-childbearing potential or must agree to use an acceptable method of contraception or abstinence, during the study, and 1 month following completion of the study
- The patient and caregiver are willing and able to participate in all schedule evaluations and complete all required tests
Who cannot join
- Patient was significantly non-compliant in Study ACP-103-032
- The Investigator becomes aware of an impending and unexpected change in the patient's living situation (e.g., change in caregiver, change in facility, moving from home to facility, moving from one family member or caregiver's home to another) that may cause a major disruption in the patient's behavior
- Patient or study partner/caregiver has a medical condition (e.g., hearing, vision impairments) that would impair the ability to perform the study assessments.
- Patient is bedridden or has any significant medical condition that is unstable and would place the patient at undue risk from study drug or study procedures
- Has clinically significant laboratory abnormalities that would jeopardize the safe participation of the patient in the study
- Has a Global Clinician Assessment of Suicidality (GCAS) score of 3 or 4 based on Investigator's assessment of behavior since the last assessment
Trial locations and contacts
28 sites in 5 countries.
28 sites in 5 countries
United States17 sites
Acadia Hospital
Bangor, Maine, 04401
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
ANI Neurology, PLLC dba Alzheimer's Memory Center
Charlotte, North Carolina, 28270
ATP Clinical Research, Inc.
Costa Mesa, California, 92626
Quantum Laboratories Inc.
Deerfield Beach, Florida, 33064
Insite Clinical Research, LLC
DeSoto, Texas, 75115
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, 07724
Neuro-Pain Medical Center
Fresno, California, 93710
Neurology Center of North Orange County
Fullerton, California, 92835
Miami Jewish Health Systems
Miami, Florida, 33137
Collier Neurologic Specialists LLC
Naples, Florida, 34105
Alzheimer's Disease Center
Quincy, Massachusetts, 02169
Pharmaceutical Research Associates, Inc.
Salt Lake City, Utah, 84107
Pacific Clinical Research Network
San Diego, California, 92103
Bio Behavioral Health
Toms River, New Jersey, 08755
Clinical Research Unit
Washington D.C., District of Columbia, 20007
Abington Neurological Associates, Ltd.
Willow Grove, Pennsylvania, 19090
Spain4 sites
Centro de Atencion Especializada Oroitu
Algorta, Viscaya, 48993
Hospital General Universitario de Elche
Elche, 03203
Hospital Universitari Mutua de Terrassa
Terrassa, 08221
Hospital Viamed Montecanal
Zaragoza, 50012
Chile3 sites
Psicomed Estudios Médicos
Antofagasta, 127-0244
Biomedica Research Group
Santiago, 7500710
Especialidades Medicas L y S
Santiago, 7560356
United Kingdom3 sites
RICE-The Research Institute for the Care of Older People, The RICE Centre, The Royal United Hospital
Bath, BA1 3NG
West London Cognitive Disorders Treatment & Research Unit, Lakeside Mental Health Unit, West Middlesex University Hosp. Site
Isleworth, TW7 6AF
Greater Manchester Mental Health NHS Foundation Trust
Manchester, M8 5RB
France1 site
CHU de Toulouse - Cite de la sante - Gerontople
Toulouse, Cedex 9, 31059
About this study
Official title: A 52-Week Open-Label Extension 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
- Being tested
- Pimavanserin
- Medical subject headings
- Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PimavanserinDrug
Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth, OR Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth
| Study group | Role | What they receive |
|---|---|---|
| Pimavanserin 20 mg OR 34 mg per day | Experimental | Not described Receives: Drug: Pimavanserin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Events (TEAEs)
Safety and tolerability of pimavanserin after 52 weeks of treatment in patients with probable Alzheimer's disease who have symptoms of agitation and Aggression, in terms of occurrence of TEAEs
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start23 Feb 2017
- Primary completion25 Feb 2019
- Study completion25 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Agitation and Aggression in Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- ACADIA Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118947
- Sponsor's protocol ID
- ACP-103-033
- Other IDs
- 2016-001128-78, 2016
- Status last verified
- Apr 2020
- First submitted
- 12 Apr 2017
- Last updated
- 9 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 52-Week Open-Label Extension Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03118947
- Acronym / sponsor ID
- ACP-103-033
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- ACADIA Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Feb 2017 (actual)
- Primary completion
- 25 Feb 2019 (actual)
- Study completion
- 25 Feb 2019 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Posted 9 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pimavanserin 20 mg OR 34 mg per day | Experimental | Drug: Pimavanserin |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must complete the Week 12 visit in Study ACP-103-032 while continuing to take his/her assigned dose of blinded study drug
- Can understand the nature of the trial and protocol requirements and provide signed informed consent
- Lives at home or in an assisted living or care facility (but has the capacity to visit the clinic as an outpatient)
- Has a designated study partner/caregiver who is in contact with the patient at least 3 times a week on 3 separate days
- Female patients must be of non-childbearing potential or must agree to use an acceptable method of contraception or abstinence, during the study, and 1 month following completion of the study
Key exclusion criteria (6 listed)
- Patient was significantly non-compliant in Study ACP-103-032
- The Investigator becomes aware of an impending and unexpected change in the patient's living situation (e.g., change in caregiver, change in facility, moving from home to facility, moving from one family member or caregiver's home to another) that may cause a major disruption in the patient's behavior
- Patient or study partner/caregiver has a medical condition (e.g., hearing, vision impairments) that would impair the ability to perform the study assessments.
- Patient is bedridden or has any significant medical condition that is unstable and would place the patient at undue risk from study drug or study procedures
- Has clinically significant laboratory abnormalities that would jeopardize the safe participation of the patient in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PimavanserinPimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth, OR Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth | Drug | Pimavanserin 20 mg OR 34 mg per day |
Primary outcome
Treatment Emergent Adverse Events (TEAEs)
Time frame: 52 weeks
Safety and tolerability of pimavanserin after 52 weeks of treatment in patients with probable Alzheimer's disease who have symptoms of agitation and Aggression, in terms of occurrence of TEAEs
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pimavanserin in people with Agitation and Aggression in Alzheimer's Disease, run by ACADIA Pharmaceuticals Inc. at 28 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Spain, Chile, United Kingdom, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Emergent Adverse Events (TEAEs) (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.