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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001128-78 | EudraCT Number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pimavanserin 20 mg OR 34 mg per day | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pimavanserin | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 52 weeks |
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Inclusion Criteria:
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
The patient and caregiver are willing and able to participate in all schedule evaluations and complete all required tests
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ATP Clinical Research, Inc. | Costa Mesa | California | 92626 | United States | ||
| Neuro-Pain Medical Center |
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Patients from parent study ACP-103-032 who were eligible to participate in this study were consented prior to the final procedures performed for study ACP-103-032 at Week 12. The ACP-103-032 Week 12 visit was also considered the baseline visit of study ACP-103-033. The ACP-103-033 result tables are all based on the safety analysis set (n=78).
This open-label extension study included patients completing double-blind, randomised, placebo-controlled study ACP-103-032 (NCT02992132).
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| ID | Title | Description |
|---|---|---|
| FG000 | All Patients | All patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 2 visit, the dose could be increased to 34 mg QD based on the investigator's assessment of clinical response. Subsequently, the dose could be adjusted from 34 mg to 20 mg or from 20 mg to 34 mg at any visit based on clinical response. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 30, 2017 | Feb 21, 2020 |
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| Fresno |
| California |
| 93710 |
| United States |
| Neurology Center of North Orange County | Fullerton | California | 92835 | United States |
| Pacific Clinical Research Network | San Diego | California | 92103 | United States |
| Clinical Research Unit | Washington D.C. | District of Columbia | 20007 | United States |
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | 33486 | United States |
| Quantum Laboratories Inc. | Deerfield Beach | Florida | 33064 | United States |
| Miami Jewish Health Systems | Miami | Florida | 33137 | United States |
| Collier Neurologic Specialists LLC | Naples | Florida | 34105 | United States |
| Acadia Hospital | Bangor | Maine | 04401 | United States |
| Alzheimer's Disease Center | Quincy | Massachusetts | 02169 | United States |
| Memory Enhancement Center of America, Inc. | Eatontown | New Jersey | 07724 | United States |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | United States |
| ANI Neurology, PLLC dba Alzheimer's Memory Center | Charlotte | North Carolina | 28270 | United States |
| Abington Neurological Associates, Ltd. | Willow Grove | Pennsylvania | 19090 | United States |
| Insite Clinical Research, LLC | DeSoto | Texas | 75115 | United States |
| Pharmaceutical Research Associates, Inc. | Salt Lake City | Utah | 84107 | United States |
| Psicomed Estudios Médicos | Antofagasta | 127-0244 | Chile |
| Biomedica Research Group | Santiago | 7500710 | Chile |
| Especialidades Medicas L y S | Santiago | 7560356 | Chile |
| CHU de Toulouse - Cite de la sante - Gerontople | Toulouse | Cedex 9 | 31059 | France |
| Centro de Atencion Especializada Oroitu | Algorta | Viscaya | 48993 | Spain |
| Hospital General Universitario de Elche | Elche | 03203 | Spain |
| Hospital Universitari Mutua de Terrassa | Terrassa | 08221 | Spain |
| Hospital Viamed Montecanal | Zaragoza | 50012 | Spain |
| RICE-The Research Institute for the Care of Older People, The RICE Centre, The Royal United Hospital | Bath | BA1 3NG | United Kingdom |
| West London Cognitive Disorders Treatment & Research Unit, Lakeside Mental Health Unit, West Middlesex University Hosp. Site | Isleworth | TW7 6AF | United Kingdom |
| Greater Manchester Mental Health NHS Foundation Trust | Manchester | M8 5RB | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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Treated patients (i.e. patients receiving at least 1 dose of open-label study drug)
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | All patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 2 visit, the dose could be increased to 34 mg QD based on the investigator's assessment of clinical response. Subsequently, the dose could be adjusted from 34 mg to 20 mg or from 20 mg to 34 mg at any visit based on clinical response. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Duration of symptoms of Alzheimer's disease | Mean | Standard Deviation | years |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Treated patients (i.e. patients receiving at least 1 dose of open-label study drug) | Posted | Count of Participants | Participants | 52 weeks |
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|
52 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Patients | All patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 2 visit, the dose could be increased to 34 mg QD based on the investigator's assessment of clinical response. Subsequently, the dose could be adjusted from 34 mg to 20 mg or from 20 mg to 34 mg at any visit based on clinical response. | 3 | 78 | 12 | 78 | 20 | 78 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebral haemorrhage | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dementia Alzheimer's type | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
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Investigator may publish the study results, relative to his/her own patients, only after review, comment and approval by the sponsor. No publication of confidential information shall be made without the sponsor's prior written consent. At least 60 days prior to submitting a manuscript or prior to any public presentation, a copy of the manuscript or presentation will be provided to the sponsor for review and comment. The sponsor has 60 days to review and comment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Dir. Medical Information and Medical Communications | ACADIA Pharmaceuticals Inc. | 858-261-2897 | medicalinformation@acadia-pharm.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 6, 2019 | Feb 21, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011595 | Psychomotor Agitation |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011596 | Psychomotor Disorders |
| D019954 | Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C510793 | pimavanserin |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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