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A Study of the Safety and Efficacy of Pimavanserin in Patients With Alzheimer's Disease Psychosis

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ClinicalTrials.gov Identifier: NCT02035553
Recruitment Status : Completed
First Posted : January 14, 2014
Results First Posted : October 25, 2017
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alzheimer's Disease Psychosis
Interventions: Drug: Pimavanserin tartrate
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Placebo, two tablets, once daily by mouth
Pimavanserin 40 mg Pimavanserin tartrate, 40 mg (two 20 mg tablets), once daily by mouth (equivalent to 34 mg free base pimavanserin)

Participant Flow:   Overall Study
    Placebo   Pimavanserin 40 mg
STARTED   91   90 
COMPLETED   73   67 
NOT COMPLETED   18   23 
Death (See All-Cause Mortality Table)                0                1 
Adverse Event                10                6 
Physician Decision                3                2 
Lack of Efficacy                1                1 
Withdrawal by Subject                4                7 
Non-compliance with Study Drug                0                1 
Lost to Follow-up                0                1 
Other Reason                0                4 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Placebo, two tablets, once daily by mouth
Pimavanserin 40 mg Pimavanserin tartrate, 40 mg (two 20 mg tablets), once daily by mouth (equivalent to 34 mg free base pimavanserin)
Total Total of all reporting groups

Baseline Measures
   Placebo   Pimavanserin 40 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 91   90   181 
Age 
[Units: Years]
Mean (Standard Deviation)
 86.1  (5.96)   85.7  (7.05)   85.9  (6.51) 
Age, Customized 
[Units: Participants]
Count of Participants
     
Age       
<=85      41  45.1%      41  45.6%      82  45.3% 
>85      50  54.9%      49  54.4%      99  54.7% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      73  80.2%      73  81.1%      146  80.7% 
Male      18  19.8%      17  18.9%      35  19.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      91 100.0%      90 100.0%      181 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Race       
Asian      0   0.0%      3   3.3%      3   1.7% 
Black or African American      1   1.1%      3   3.3%      4   2.2% 
White      89  97.8%      84  93.3%      173  95.6% 
Other      1   1.1%      0   0.0%      1   0.6% 
Region of Enrollment 
[Units: Participants]
     
United Kingdom   91   90   181 


  Outcome Measures

1.  Primary:   Antipsychotic Efficacy   [ Time Frame: Day 43 ]


  Serious Adverse Events

Time Frame 12 weeks
Additional Description From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43, 64 and Day 85, and at the 4-week follow-up phone call.

Reporting Groups
  Description
Placebo Placebo, two tablets, once daily by mouth
Pimavanserin 40 mg Pimavanserin tartrate, 40 mg (two 20 mg tablets), once daily by mouth (equivalent to 34 mg free base pimavanserin)

Serious Adverse Events
    Placebo   Pimavanserin 40 mg
Total, All-Cause Mortality     
# participants affected / at risk   4/91 (4.40%)   4/90 (4.44%) 
Total, Serious Adverse Events     
# participants affected / at risk   10/91 (10.99%)   15/90 (16.67%) 
Cardiac disorders     
Cardiopulmonary failure † 1     
# participants affected / at risk   1/91 (1.10%)   0/90 (0.00%) 
# events   1   0 
Myocardial infarction † 1     
# participants affected / at risk   2/91 (2.20%)   0/90 (0.00%) 
# events   2   0 
General disorders     
General physical health deterioration † 1 [3]     
# participants affected / at risk   1/91 (1.10%)   0/90 (0.00%) 
# events   1   0 
Infections and infestations     
Pneumonia † 1     
# participants affected / at risk   2/91 (2.20%)   2/90 (2.22%) 
# events   2   3 
Urinary tract infection † 1     
# participants affected / at risk   0/91 (0.00%)   2/90 (2.22%) 
# events   0   2 
Bronchopneumonia † 1     
# participants affected / at risk   0/91 (0.00%)   1/90 (1.11%) 
# events   0   1 
Lower respiratory tract infection † 1     
# participants affected / at risk   0/91 (0.00%)   1/90 (1.11%) 
# events   0   1 
Injury, poisoning and procedural complications     
Fall † 1     
# participants affected / at risk   0/91 (0.00%)   1/90 (1.11%) 
# events   0   1 
Femoral neck fracture † 1     
# participants affected / at risk   0/91 (0.00%)   1/90 (1.11%) 
# events   0   1 
Hip fracture † 1     
# participants affected / at risk   0/91 (0.00%)   1/90 (1.11%) 
# events   0   1 
Laceration † 1     
# participants affected / at risk   0/91 (0.00%)   1/90 (1.11%) 
# events   0   1 
Spinal fracture † 1     
# participants affected / at risk   1/91 (1.10%)   0/90 (0.00%) 
# events   1   0 
Upper limb fracture † 1     
# participants affected / at risk   1/91 (1.10%)   0/90 (0.00%) 
# events   1   0 
Wrist fracture † 1     
# participants affected / at risk   1/91 (1.10%)   0/90 (0.00%) 
# events   1   0 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant neoplasm of thorax † 1     
# participants affected / at risk   0/91 (0.00%)   1/90 (1.11%) 
# events   0   1 
Nervous system disorders     
Dementia † 1     
# participants affected / at risk   0/91 (0.00%)   1/90 (1.11%) 
# events   0   1 
Depressed level of consciousness † 1     
# participants affected / at risk   0/91 (0.00%)   1/90 (1.11%) 
# events   0   1 
Loss of consciousness † 1     
# participants affected / at risk   1/91 (1.10%)   1/90 (1.11%) 
# events   1   1 
Transient ischaemic attack † 1     
# participants affected / at risk   0/91 (0.00%)   1/90 (1.11%) 
# events   0   1 
Psychiatric disorders     
Aggression † 1     
# participants affected / at risk   0/91 (0.00%)   1/90 (1.11%) 
# events   0   1 
Renal and urinary disorders     
Renal failure acute † 1     
# participants affected / at risk   0/91 (0.00%)   1/90 (1.11%) 
# events   0   1 
Vascular disorders     
Hypotension † 1     
# participants affected / at risk   1/91 (1.10%)   0/90 (0.00%) 
# events   1   0 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 17.0
[3] General disorders and administration site conditions




  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: James Youakim, Vice President, Clinical Development
Organization: ACADIA Pharmaceuticals Inc.
phone: 609-250-6900
e-mail: jyouakim@acadia-pharm.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02035553     History of Changes
Other Study ID Numbers: ACP-103-019
First Submitted: January 13, 2014
First Posted: January 14, 2014
Results First Submitted: September 28, 2017
Results First Posted: October 25, 2017
Last Update Posted: October 25, 2017