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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
Enrollment 181

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Pimavanserin 40 mg
Hide Arm/Group Description Placebo, two tablets, once daily by mouth Pimavanserin tartrate, 40 mg (two 20 mg tablets), once daily by mouth (equivalent to 34 mg free base pimavanserin)
Period Title: Overall Study
Started 91 90
Completed 73 67
Not Completed 18 23
Reason Not Completed
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
Arm/Group Title Placebo Pimavanserin 40 mg Total
Hide Arm/Group Description Placebo, two tablets, once daily by mouth Pimavanserin tartrate, 40 mg (two 20 mg tablets), once daily by mouth (equivalent to 34 mg free base pimavanserin) Total of all reporting groups
Overall Number of Baseline Participants 91 90 181
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 91 participants 90 participants 181 participants
86.1  (5.96) 85.7  (7.05) 85.9  (6.51)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age Number Analyzed 91 participants 90 participants 181 participants
<=85
41
  45.1%
41
  45.6%
82
  45.3%
>85
50
  54.9%
49
  54.4%
99
  54.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 90 participants 181 participants
Female
73
  80.2%
73
  81.1%
146
  80.7%
Male
18
  19.8%
17
  18.9%
35
  19.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 90 participants 181 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 91 participants 90 participants 181 participants
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  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 91 participants 90 participants 181 participants
91 90 181
1.Primary Outcome
Title Antipsychotic Efficacy
Hide Description Change from Baseline to Day 43 in the Neuropsychiatric Inventory-Nursing Home Version (NPI-NH) psychosis score (Delusions [Domain A]+Hallucinations [Domain B]) in the Full Analysis Set (FAS). The NPI-NH is a questionnaire that quantifies behavioral changes in dementia in nursing home patients and evaluates 12 behavioral domains. For each of the 12 behavioral domains the Frequency (scale:1=occasionally to 4=very frequently) is multiplied by the Severity (scale:1=Mild to 3=Severe) to obtain a domain score (frequency x severity), The NPI-NH Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual domain scores, to yield a possible total score of 0 to 24. Lower scores correspond to less severity. A negative change score from baseline indicates improvement.
Time Frame Day 43
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects who received at least one dose of study treatment and have both a Baseline and at least one post-Baseline NPI-NH psychosis score evaluation.
Arm/Group Title Placebo Pimavanserin 40 mg
Hide Arm/Group Description:
Placebo, two tablets, once daily by mouth
Pimavanserin tartrate, 40 mg (two 20 mg tablets), once daily by mouth (equivalent to 34 mg free base pimavanserin)
Overall Number of Participants Analyzed 91 87
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on the NPI-NH scale
-1.93
(-3.18 to -0.67)
-3.76
(-5.05 to -2.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pimavanserin 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0451
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Diff in MMRM LSM
Estimated Value -1.84
Confidence Interval (2-Sided) 95%
-3.64 to -0.04
Estimation Comments [Not Specified]
Time Frame 12 weeks
Adverse Event Reporting 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.
 
Arm/Group Title Placebo Pimavanserin 40 mg
Hide Arm/Group Description Placebo, two tablets, once daily by mouth Pimavanserin tartrate, 40 mg (two 20 mg tablets), once daily by mouth (equivalent to 34 mg free base pimavanserin)
All-Cause Mortality
Placebo Pimavanserin 40 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   4/91 (4.40%)      4/90 (4.44%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Pimavanserin 40 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/91 (10.99%)      15/90 (16.67%)    
Cardiac disorders     
Cardiopulmonary failure  1  1/91 (1.10%)  1 0/90 (0.00%)  0
Myocardial infarction  1  2/91 (2.20%)  2 0/90 (0.00%)  0
General disorders     
General physical health deterioration  1 [1]  1/91 (1.10%)  1 0/90 (0.00%)  0
Infections and infestations     
Pneumonia  1  2/91 (2.20%)  2 2/90 (2.22%)  3
Urinary tract infection  1  0/91 (0.00%)  0 2/90 (2.22%)  2
Bronchopneumonia  1  0/91 (0.00%)  0 1/90 (1.11%)  1
Lower respiratory tract infection  1  0/91 (0.00%)  0 1/90 (1.11%)  1
Injury, poisoning and procedural complications     
Fall  1  0/91 (0.00%)  0 1/90 (1.11%)  1
Femoral neck fracture  1  0/91 (0.00%)  0 1/90 (1.11%)  1
Hip fracture  1  0/91 (0.00%)  0 1/90 (1.11%)  1
Laceration  1  0/91 (0.00%)  0 1/90 (1.11%)  1
Spinal fracture  1  1/91 (1.10%)  1 0/90 (0.00%)  0
Upper limb fracture  1  1/91 (1.10%)  1 0/90 (0.00%)  0
Wrist fracture  1  1/91 (1.10%)  1 0/90 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant neoplasm of thorax  1  0/91 (0.00%)  0 1/90 (1.11%)  1
Nervous system disorders     
Dementia  1  0/91 (0.00%)  0 1/90 (1.11%)  1
Depressed level of consciousness  1  0/91 (0.00%)  0 1/90 (1.11%)  1
Loss of consciousness  1  1/91 (1.10%)  1 1/90 (1.11%)  1
Transient ischaemic attack  1  0/91 (0.00%)  0 1/90 (1.11%)  1
Psychiatric disorders     
Aggression  1  0/91 (0.00%)  0 1/90 (1.11%)  1
Renal and urinary disorders     
Renal failure acute  1  0/91 (0.00%)  0 1/90 (1.11%)  1
Vascular disorders     
Hypotension  1  1/91 (1.10%)  1 0/90 (0.00%)  0
1
Term from vocabulary, MedDRA 17.0
Indicates events were collected by systematic assessment
[1]
General disorders and administration site conditions
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Pimavanserin 40 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   70/91 (76.92%)      67/90 (74.44%)    
Blood and lymphatic system disorders     
Anaemia  1  8/91 (8.79%)  8 9/90 (10.00%)  9
General disorders     
Oedema peripheral  1 [1]  2/91 (2.20%)  2 7/90 (7.78%)  7
Infections and infestations     
Urinary tract infection  1  25/91 (27.47%)  36 18/90 (20.00%)  27
Lower respiratory tract infection  1  12/91 (13.19%)  13 13/90 (14.44%)  15
Cellulitis  1  3/91 (3.30%)  3 6/90 (6.67%)  7
Injury, poisoning and procedural complications     
Fall  1  21/91 (23.08%)  35 20/90 (22.22%)  39
Contusion  1  14/91 (15.38%)  17 11/90 (12.22%)  16
Laceration  1  5/91 (5.49%)  6 3/90 (3.33%)  3
Investigations     
Blood urea increased  1  8/91 (8.79%)  8 7/90 (7.78%)  7
Blood potassium increased  1  3/91 (3.30%)  3 5/90 (5.56%)  5
Blood lactate dehydrogenase increase  1  10/91 (10.99%)  10 4/90 (4.44%)  4
Blood alkaline phosphatase increased  1  8/91 (8.79%)  8 3/90 (3.33%)  3
Metabolism and nutrition disorders     
Hyperglycaemia  1  11/91 (12.09%)  11 4/90 (4.44%)  4
Nervous system disorders     
Somnolence  1  7/91 (7.69%)  7 3/90 (3.33%)  3
Psychiatric disorders     
Agitation  1  13/91 (14.29%)  13 19/90 (21.11%)  19
Aggression  1  4/91 (4.40%)  4 9/90 (10.00%)  10
Anxiety  1  2/91 (2.20%)  2 5/90 (5.56%)  5
Behavioural and psychiatric symptoms of dementia  1  2/91 (2.20%)  2 5/90 (5.56%)  6
Skin and subcutaneous tissue disorders     
Rash  1  7/91 (7.69%)  7 4/90 (4.44%)  4
1
Term from vocabulary, MedDRA 17.0
Indicates events were collected by systematic assessment
[1]
General disorders and administration site conditions
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.
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.
Results Point of Contact
Name/Title: James Youakim, Vice President, Clinical Development
Organization: ACADIA Pharmaceuticals Inc.
Phone: 609-250-6900
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