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 Investigational Drug (Pimavanserin) for PD Psychosis 
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Joined: Fri Aug 11, 2006 1:46 pm
Posts: 4811
Location: SF Bay Area (Northern CA)
Post 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 person’s 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:

http://www.pdtrials.org/en/browse/all/view/206

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

Summary

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.

Study Phase
Phase 3

Symptoms Addressed: Non-movement Symptoms
Cognitive, Moods, Delusions, Hallucinations, Psychosis

Time Commitment
Less than six months
Weekly through Day 15 and then biweekly.

Eligibility
Minimum Age: 40
Gender(s) Accepted: Either
Minimum Years Since Diagnosis: 1

Inclusion Criteria
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

Enrollment
Expected Enrollment: 280 (US)
Date Enrollment Began: Jun 01 2007
Last Updated Date: Jan 16 2008
Trial Post Date: Jan 16 2008
Website: http://www.parkinsonsbodymind.com/

Primary Contacts and Locations

All States
ACADIA PARKINSON'S DISEASE CLINICAL TRIAL
Phone: (866) 565-0262
All States
USA

Local Contacts and Locations ...
Arizona
Gilbert, AZ 85234
USA

Phoenix, AZ 85013
USA

California
Fountain Valley, CA 92708
USA

Berkeley, CA 94705
USA

Carson, CA 90746
USA

Irvine, CA 92697
USA

La Habra, CA 90631
USA

Sunnyvale, CA 94805
USA

Connecticut
Fairfield, CT 06824
USA

Danbury, CT 06810
USA

Florida
Boca Raton, FL 33486
USA

Pompano Beach, FL 33060
USA

Gainesville, FL 32610
USA

Port Charlotte, FL 33952
USA

St. Petersburg, FL 33701
USA

Tampa, FL 33606
USA

Georgia
Decatur, GA 30033
USA

Augusta, GA 30912
USA

Massachusetts
Worcester, MA 01655
USA

Maine
Scarborough, ME 04074
USA

Michigan
Traverse City, MI
USA

North Carolina
Asheville, NC 28806
USA

Salisbury, NC 28144
USA

New Jersey
Toms River, NJ 08755
USA

New York
Kingston, NY 12401
USA

Rochester, NY 14618
USA

Ohio
Columbus, OH 43210
USA

Rhode Island
Warwick, RI 02886
USA

Tennessee
Brentwood, TN 37027
USA

Washington
Kirkland, WA 98034
USA

Spokane, WA 99204
USA


Wed Feb 04, 2009 2:28 am
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Joined: Fri Aug 11, 2006 1:46 pm
Posts: 4811
Location: SF Bay Area (Northern CA)
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I called Kimberly Wilson at Acadia Pharmaceuticals this morning. A diagnosis of Dementia with Lewy Bodies and an MMSE score lower than 21 are both exclusionary factors in the study. So we'll have to wait until the FDA approves the drug.


Wed Feb 11, 2009 2:38 pm
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