Agitation and Aggression in Alzheimer's DiseasePhase 2NCT02992132

Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease (SERENE)

A Phase 2 study testing Pimavanserin 34 mg and Pimavanserin 20 mg in people with Agitation and Aggression in Alzheimer's Disease, run by ACADIA Pharmaceuticals Inc. at 56 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

To evaluate the efficacy of pimavanserin compared with placebo in treatment of agitation and aggression after 12 weeks of treatment 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 34 mg and Pimavanserin 20 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 111 participants
Where: 56 sitesin 5 countries
Study dates: Nov 2016to 16 Feb 2018
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

Male or female, 50 years of age or older
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.
Has a diagnosis of probable AD according to the National Institute on Aging-Alzheimer's Association (NIA-AA) guidelines
Meets criteria for agitation according to the International Psychogeriatric Association (IPA) guidelines

Show all 10Show fewer

Lives at home or in an assisted living or care facility (but has the capacity to visit the clinic as an outpatient). Subjects must have been at their current location for at least 3 weeks prior to Screening and plan to remain at the same location for the duration of the trial.
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 , for at least 1 month prior to randomization, 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

The agitation/aggression is attributable to concomitant medications, environmental conditions, substance abuse, or active medical or psychiatric condition
Patient is receiving skilled nursing care for any medical condition other than dementia
Treatment with an antipsychotic medication within 2 weeks of Baseline visit or 5 half lives, whichever is longer
Patient or study partner/caregiver has a medical condition (e.g., hearing, vision impairments) that would impair the ability to perform the study assessments.
Has had a myocardial infarction within the last six months
Has a history or symptoms of long QT syndrome

Show all 10Show fewer

Has a history of a significant psychotic disorder before or during the diagnosis of probable Alzheimer's disease (including, but not limited to schizophrenia or bipolar disorder)
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 9. Has a sensitivity to pimavanserin or its excipients
10. Has previously participated in a clinical study with pimavanserin
11. Has a Global Clinician Assessment of Suicidality (GCAS) score of 3 or 4 based on Investigator's assessment of behavior within the last 3 months at Screening or since last visit at Baseline

Trial locations and contacts

56 sites in 5 countries.

Country

City, postcode or hospital

56 sites in 5 countries

United States33 sites

Study site
Albuquerque, New Mexico, 87131
Study site
Atlanta, Georgia, 30322
Study site
Bangor, Maine, 04401
Study site
Boca Raton, Florida, 33486
Study site
Charleston, South Carolina, 29401
Study site
Charlotte, North Carolina, 28270
Study site
Clinton Township, Michigan, 48035
Study site
Costa Mesa, California, 92626
Study site
Danbury, Connecticut, 06810
Study site
Deerfield Beach, Florida, 33064
Study site
DeSoto, Texas, 75115
Study site
Eatontown, New Jersey, 07724
Study site
Flowood, Mississippi, 39232
Study site
Fresno, California, 93710
Study site
Fullerton, California, 92835
Study site
Jackson, Mississippi, 39216
Study site
Jenkintown, Pennsylvania, 19046
Study site
Los Angeles, California, 90073
Study site
Marlton, New Jersey, 08053
Study site
Medford, Oregon, 97504
Study site
Miami, Florida, 33137
Study site
Naples, Florida, 34102
Study site
Nashville, Tennessee, 37212
Study site
Norristown, Pennsylvania, 19401
Study site
Oklahoma City, Oklahoma, 73112
Study site
Pasadena, California, 91105
Study site
Quincy, Massachusetts, 02169
Study site
Salt Lake City, Utah, 84124
Study site
San Diego, California, 92103
Study site
Spokane, Washington, 99202
Study site
Toms River, New Jersey, 08755
Study site
Washington D.C., District of Columbia, 20007
Study site
Willow Grove, Pennsylvania, 19090

Other trials in United States

Spain9 sites

Study site
Algorta, Vizcaya, 48993
Study site
Córdoba, 14011
Study site
Elche, 03203
Study site
Madrid, 28044
Study site
Palma de Mallorca, 07010
Study site
Pamplona, 31014
Study site
Santa Coloma de Gramenet, 08921
Study site
Terrassa, 08221
Study site
Zaragoza, 50012

Other trials in Spain

France5 sites

Study site
Paris, 75010
Study site
Saint-Herblain, 44800
Study site
Strasbourg, 67200
Study site
Toulouse, Cedex 9, 31059
Study site
Villeurbanne, 69100

Other trials in France

United Kingdom5 sites

Study site
Bath, BA1 3NG
Study site
Isleworth, TW7 6AF
Study site
Manchester, M21 9UN
Study site
Northampton, NN5 6UD
Study site
Swindon, Wiltshire, SN3 6BW

Other trials in United Kingdom

Chile4 sites

Study site
Antofagasta, 1270244
Study site
Santiago, 7500710
Study site
Santiago, 7560356
Study site
Valdivia, Los Ríos Region, 5090000

Other trials in Chile

About this study

Official 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

To evaluate the efficacy of pimavanserin compared with placebo in treatment of agitation and aggression after 12 weeks of treatment

Conditions: Agitation and Aggression in Alzheimer's Disease
Being tested: Pimavanserin 34 mg, Pimavanserin 20 mg, Placebo
Medical subject headings: Psychomotor Agitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pimavanserin 34 mgDrug
Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth
Pimavanserin 20 mgDrug
Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth
PlaceboOther
Placebo, taken as two tablets, once daily by mouth

Study groups in NCT02992132
Study group	Role	What they receive
Pimavanserin 34 mg	Experimental	Drug- pimavanserin tartrate, 34 mg, taken as two 17 mg tablets, once daily by mouth Receives: Drug: Pimavanserin 34 mg
Pimavanserin 20 mg	Experimental	Drug- pimavanserin tartrate, 20 mg, taken as two 10 mg tablets, once daily by mouth Receives: Drug: Pimavanserin 20 mg
Placebo	Placebo comparator	Placebo, taken as two tablets, once daily by mouth Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Cohen-Mansfield Agitation Inventory (CMAI)
The Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item scale to assess agitation. Each item is rated on a 7-point scale of frequency, from least (1) to most frequent (7). Items are summed to calculate the CMAI total score. The CMAI total score has a range of 29-203 points; higher scores indicate more severe agitation
Measured: Baseline to 12 weeks

Secondary outcomes (1)

Zarit Burden Interview
The Zarit Burden Interview (ZBI) assess the stresses experienced by caregivers of patients with dementia. It assesses 22 questions about the impact of the patient's disabilities on the caregiver's life, each rated from least (0) to most (4) frequent. Items are summed to calculate the ZBI total score. The ZBI total score ranges from 0 to 88; higher scores denoting more stresses experienced by caregivers.
Measured: Baseline to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 201616 Feb 2018

First posted14 Dec 2016 (estimated)
Study startNov 2016
Primary completion25 Jan 2018
Study completion16 Feb 2018

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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 111 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02992132
Sponsor's protocol ID: ACP-103-032
Other IDs: 2016-001127-32, 2016
Status last verified: Mar 2019
First submitted: 12 Dec 2016
Last updated: 28 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Virtual Reality to Advance Dementia Care and Quality of Life
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Active, not recruitingPhase 2
Clinical Trial on Agitation in Alzheimer's Dementia
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Human Mesenchymal Stem Cells (hMSC) in Behavioral Problems Due to Alzheimer's Disease.
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Standardizing Care for Neuropsychiatric Symptoms and Quality of Life in Dementia
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All Agitation and Aggression in Alzheimer's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT02992132
Acronym / sponsor ID: ACP-103-032
Conditions: Agitation and Aggression in Alzheimer's Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 111 participants (actual)
Lead sponsor: ACADIA Pharmaceuticals Inc.Industry (pharma, biotech, devices)
Study start: Nov 2016
Primary completion: 25 Jan 2018 (actual)
Study completion: 16 Feb 2018 (actual)
First posted: 14 Dec 2016 (estimated)
Results: Posted 28 Mar 2019

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 efficacy of pimavanserin compared with placebo in treatment of agitation and aggression after 12 weeks of treatment

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Pimavanserin 34 mg	Experimental	Drug: Pimavanserin 34 mgDrug- pimavanserin tartrate, 34 mg, taken as two 17 mg tablets, once daily by mouth
Pimavanserin 20 mg	Experimental	Drug: Pimavanserin 20 mgDrug- pimavanserin tartrate, 20 mg, taken as two 10 mg tablets, once daily by mouth
Placebo	Placebo comparator	Other: PlaceboPlacebo, taken as two tablets, once daily by mouth

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Male or female, 50 years of age or older
Can understand the nature of the trial and protocol requirements and provide signed informed consent
Has a diagnosis of probable AD according to the National Institute on Aging-Alzheimer's Association (NIA-AA) guidelines
Meets criteria for agitation according to the International Psychogeriatric Association (IPA) guidelines
Lives at home or in an assisted living or care facility (but has the capacity to visit the clinic as an outpatient). Subjects must have been at their current location for at least 3 weeks prior to Screening and plan to remain at the same location for the duration of the trial.

Key exclusion criteria (10 listed)

The agitation/aggression is attributable to concomitant medications, environmental conditions, substance abuse, or active medical or psychiatric condition
Patient is receiving skilled nursing care for any medical condition other than dementia
Treatment with an antipsychotic medication within 2 weeks of Baseline visit or 5 half lives, whichever is longer
Patient or study partner/caregiver has a medical condition (e.g., hearing, vision impairments) that would impair the ability to perform the study assessments.
Has had a myocardial infarction within the last six months

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
Pimavanserin 34 mgPimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth	Drug	Pimavanserin 34 mg
Pimavanserin 20 mgPimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth	Drug	Pimavanserin 20 mg
PlaceboPlacebo, taken as two tablets, once daily by mouth	Other	Placebo

Primary outcome

Cohen-Mansfield Agitation Inventory (CMAI)
Time frame: Baseline to 12 weeks
The Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item scale to assess agitation. Each item is rated on a 7-point scale of frequency, from least (1) to most frequent (7). Items are summed to calculate the CMAI total score. The CMAI total score has a range of 29-203 points; higher scores indicate more severe agitation

1 secondary outcome

Zarit Burden Interview
Time frame: Baseline to 12 weeks

Results and safety

Results posted to the registry on 28 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	40	27
Pimavanserin 20 mg	35	27
Pimavanserin 34 mg	36	29

Primary outcome: Cohen-Mansfield Agitation Inventory (CMAI)

Time frame: Baseline to 12 weeks. Mean (Standard Error). Unit: score on a scale

Measure	Placebo n = 37	Pimavanserin 20 mg n = 34	Pimavanserin 34 mg n = 35
Baseline	70.3 (4.5)	56.9 (2.2)	68.0 (3.3)
Week 12	54.3 (4.3)	52.5 (4.3)	53.7 (3.0)
Week 12 change from baseline	-16.8 (5.0)	-3.7 (3.7)	-12.3 (2.7)

Placebo vs Pimavanserin 20 mg: Difference in LSM: 5.1 (95% CI -4.8 to 15.0)
Placebo vs Pimavanserin 34 mg: Difference in LSM: 1.0 (95% CI -8.5 to 10.5)

Population analysed: Full Analysis set, i.e. patients who had been randomized and treated and had both a baseline value and at least 1 post-baseline value for the CMAI total score.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	3 of 40 (7.5%)	11 of 40 (27.5%)	0 of 40
Pimavanserin 20 mg	4 of 35 (11.4%)	15 of 35 (42.9%)	0 of 35
Pimavanserin 34 mg	3 of 36 (8.3%)	15 of 36 (41.7%)	0 of 36

Limitations and caveats (from the sponsor): The original study (n=432) was powered to detect a treatment effect on CMAI, however recruitment was discontinued early for business reasons and amended accordingly The final study (n=111) was no longer adequately powered to detect a treatment effect

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Agitation and Aggression in Alzheimer's Disease

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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.

56 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 34 mg and Pimavanserin 20 mg in people with Agitation and Aggression in Alzheimer's Disease, run by ACADIA Pharmaceuticals Inc. at 56 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 10 inclusion and 10 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: stopped early, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States, Spain, France, United Kingdom, Chile. 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. Some participants in this study may receive a placebo. 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 28 Mar 2019). 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?

Cohen-Mansfield Agitation Inventory (CMAI) (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02992132.

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 28 Mar 2019.