Beyond Tremor

Clinical trial to study drugs for Parkinson’s disease symptoms.

Parkinson’s disease is a disorder of the central nervous system, which includes the brain and spinal cord. Each year, about 60,000 people are diagnosed with the disease, the most common symptoms of which include tremors, which are involuntary movements in the hands, arms, legs or head.

While difficulties with motor movements are the most common and well-recognized symptoms of Parkinson’s disease, some patients with the disease also suffer with certain neuropsychiatric symptoms.

“About thirty percent of Parkinson’s patients develop delusions, hallucinations, depression, impulse control problems and other behavior and mood changes,” states Stuart J. Shafer, MD, president of Vero Beach Neurology and Research Institute.

“It is not well-understood why some patients experience these symptoms, but they may have more abnormalities in their temporal lobes and possibly their frontal lobes than patients who do not experience these symptoms.”

Dr. Shafer is the principal investigator in a clinical trial his institute is conducting in collaboration with Geodyssey Research, studying two drugs for treating symptoms of Parkinson’s disease other than tremors.

Geodyssey Research is a research organization in Vero Beach founded in 2002. Its staff are well-versed in all aspects of conducting clinical research, from the patient level to the sponsor level. Geodyssey Research began with two clinical trials in 2003 and has now completed more than 140 research studies.

Vero Beach Neurology and Research Institute has been conducting clinical research since 2000 and has been involved in 60 national and international clinical trials. Among them are several studies researching aspects of Parkinson’s disease. The institute also does research on multiple sclerosis, stroke, epilepsy and other neurological disease processes.

The clinical trial Dr. Shafer and Geodyssey Research are initiating will investigate the safety and effectiveness of two medications for treating delusions, hallucinations and other neuropsychiatric symptoms of Parkinson’s disease. They are currently enrolling patients for the study.

“Some Parkinson’s patients who experience delusions have what are called friendly boarders, which are essentially beings that live in their homes with them,” Dr. Shafer explains. “The patients know these beings are not real, but they see them as though they are as real as day. I have had patients who have groups of these boarders that they live with and interact with, but they don’t bother the patients. These delusions are also called peduncular hallucinations.

“Again, we do not know why these hallucinations or the other neuropsychiatric symptoms occur,” Dr. Shafer continues. “But we believe it has to do with an imbalance of dopamine as well as other neurotransmitters in the brain. Our goal with the clinical trial is to research ways to mitigate some of these neuropsychiatric symptoms, not just the slowness and tremor of Parkinson’s disease.”

Traditionally, doctors have used medications called atypical neuroleptics to treat the neuropsychiatric symptoms of Parkinson’s disease. Atypical neuroleptics are sometimes used in psychiatry to treat delirium, agitation and hallucinations.

“Neuroleptic medications help some of the neuropsychiatric symptoms of Parkinson’s disease, such as delusions,” Dr. Shafer notes. “But they are not effective on other symptoms and are not an ideal treatment. This is the main reason we are conducting a clinical trial of new medications.

“The first medication we are studying is low-dose pimavanserin. The second medication is quetiapine, which is already on the market as SEROQUEL®. That is a neuroleptic medicine that is often used in psychiatry for behavioral problems, but it has not been specifically compared against similar investigational medicines or for Parkinson’s disease.

“During the trial, we will be evaluating the safety and tolerability of these medications. We will compare them against placebo, which means some patients in the study will not receive the study medication. We will also be looking at the impact neuropsychiatric symptoms have on patients with Parkinson’s.”

Dealing with the neuropsychiatric symptoms is very important for the overall management of patients with Parkinson’s disease, for both the patients and their caregivers, Dr. Shafer observes.

“It’s one thing if patients are slow and shaking, but when they have delusions or hallucinations, are depressed or have other cognitive issues, then it becomes much more difficult to manage their care,” he says. “It is also more difficult for patients to manage themselves because they are not in a good place mentally.”

Study Specifics

To participate in the study, patients must meet certain criteria. They must be between 50 and 85 years old, have been diagnosed with Parkinson’s disease for at least one year, have one or more of the neuropsychiatric symptoms described below and have a reliable person to be with them during the study period. There are other requirements that will be discussed with them by the study staff.

“The staff will go over all the risks and benefits of participating in the trial in detail,” Dr. Shafer assures. “Those patients who meet the requirements will enter a four-week treatment period and will be assigned to take either one of the two investigational drugs or placebo.

“Medication assignments are made randomly. One-third of the participants will be assigned to take placebo, and two-thirds will be assigned to take one of the two investigational drugs.”

All medical exams, study procedures and study drugs are provided to qualified participants at no cost. Reimbursement of travel expenses incurred while taking part in the study may also be available.

Print This Article