Investigational Drug (Pimavanserin) for PD Psychosis
This investigational drug study called Pimavanserin for those with PD psychosis is listed on the PDtrials website. I don't know if those with DLB are eligible to participate. If anyone finds out, please pass the word along! I've sent email to the study coordinator, and will let you know what I find out. Many locations are listed but cities only. I also tried to get further details on clinicaltrials.gov, as the study is listed there also, but there are no more details there than on PDtrials.org. (On clinicaltrials.gov, I suggest doing a search for "Acadia Parkinson's Disease.")
The study website is www.ParkinsonsBodyMind.com
and the study phone number is 1-866-565-0262.
A couple of my posts from 2008 briefly mention this drug and trial:
"Pimavanserin, now in Phase III trials, is a novel drug that blocks subtypes of dopamine and serotonin receptors. Its goal is to treat the psychotic symptoms that sometimes emerge in advanced PD, without worsening a personâs motor symptoms." ("Medications for Parkinson's Disease: What's on the Horizon?," by David B. Sommer, M.D., M.P.H., and Mark A. Stacy, M.D., in the Parkinson's Disease Foundation Fall '08 Newsletter)
"Acadia ACP-103 is a drug for psychosis that will be studied soon." ("What's in the PD Pipeline," Parkinson's Disease Foundation webcast, 5/9/08)
Here's the info from PDtrials.org:
Efficacy and Safety Research Study of the Investigational Drug, Pimavanserin, in People With Parkinson's Disease Psychosis - New Information Added!
Official Study Title: A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103(Pimavanserin) in the Treatment of Psychosis in Parkinson's Disease
Sponsor: ACADIA Pharmaceuticals Inc.
Clinicaltrials.gov ID: NCT00477672
Study ID: ACP-103-012
Studies have suggested that up to 40 percent of people with Parkinson's disease (PD) will develop psychotic symptoms, commonly consisting of visual hallucinations and delusions (people with these symptoms or caregivers often mistake these symptoms for dementia) . The development of psychosis in people with PD is a major event in the clinical Clinical
progression of this disease. It disrupts their ability to perform many of the activities of daily living that keep them independent and active. As a result, PD psychosis is the most common factor leading to nursing home placements of people with PD.
The purpose of this research study is to evaluate the safety and efficacy of a new investigational drug, pimavanserin (ACP-103), in participants with PD-related psychosis. Eligible participants will be evaluated at screening Screening to ensure that all criteria for study participation are met. These evaluations will include determination of the presence of hallucinations or delusions, memory loss, and general health of the participant. People may be excluded from the study based on the presence or absence of symptoms and medical conditions identified in this screening assessment.
Participants selected for the study will be randomly assigned (flip of the coin), to either one of two doses of pimavanserin or placebo (an inactive look-alike pill) and will take the study drug once daily by mouth for six weeks and then will be followed for an additional four weeks. Participants and their caregivers return to the clinic six times for both efficacy and safety evaluations. Two hundred and eighty participants are to be enrolled in 50 sites across the U.S. and Europe. The total duration of participation is approximately 13 weeks. An open label extension study in which all participants receive pimavanserin is available for those participants who complete the study and qualify.
Below is a list of cities where the study is being conducted. To check if a study center is enrolling in your area, please visit the study website www.ParkinsonsBodyMind.com
or call 1-866-565-0262 today.
Symptoms Addressed: Non-movement Symptoms
Cognitive, Moods, Delusions, Hallucinations, Psychosis
Less than six months
Weekly through Day 15 and then biweekly.
Minimum Age: 40
Gender(s) Accepted: Either
Minimum Years Since Diagnosis: 1
Either male or female
Age 40 and above
Established diagnosis of PD for at least 1 year
Experiencing visual or auditory hallucinations and/or delusions for at least 1 month
Willing and able to attend and participate in all study visits, with a caregiver if necessary
Expected Enrollment: 280 (US)
Date Enrollment Began: Jun 01 2007
Last Updated Date: Jan 16 2008
Trial Post Date: Jan 16 2008
Primary Contacts and Locations
ACADIA PARKINSON'S DISEASE CLINICAL TRIAL
Phone: (866) 565-0262
Local Contacts and Locations ...
Gilbert, AZ 85234
Phoenix, AZ 85013
Fountain Valley, CA 92708
Berkeley, CA 94705
Carson, CA 90746
Irvine, CA 92697
La Habra, CA 90631
Sunnyvale, CA 94805
Fairfield, CT 06824
Danbury, CT 06810
Boca Raton, FL 33486
Pompano Beach, FL 33060
Gainesville, FL 32610
Port Charlotte, FL 33952
St. Petersburg, FL 33701
Tampa, FL 33606
Decatur, GA 30033
Augusta, GA 30912
Worcester, MA 01655
Scarborough, ME 04074
Traverse City, MI
Asheville, NC 28806
Salisbury, NC 28144
Toms River, NJ 08755
Kingston, NY 12401
Rochester, NY 14618
Columbus, OH 43210
Warwick, RI 02886
Brentwood, TN 37027
Kirkland, WA 98034
Spokane, WA 99204