Studies for Parkinson's Disease Patients Not Receiving Any Treatment

Pioglitazone in Early Parkinson's Disease

Purpose: This is a multi-center, double-blind, placebo controlled clinical trial of two dosages of oral pioglitazone (15 mg and 45 mg) for safety, tolerability, and futility.

Duration: 44 Weeks

Study Design: double-blind, randomized, placebo-controlled

Inclusion Criteria:
30 years and older
Men and women with idiopathic Parkinson's Disease of less than 5 years duration from diagnosis On stable dosage of rasagiline 1 mg/day or selegiline 10 mg/day for at least 8 weeks but not more than 8 months prior to baseline.
The clinical signs must be asymmetric.
Subjects may be taking stable doses (30 days) of anticholinergics, creatine (< 5gm/day) or Coenzyme Q10 (< 600 mg/day) but must be expected to remain on the same dose.

Exclusion Criteria:
Presence of freezing.
History of congestive heart failure.
Type I or Type II diabetes mellitus.
Known history of osteoporosis.
Drug or alcohol use or dependence that would interfere with the safe conduct of the study. Current or planned use of gemfibrozil or rifampin during the trial.
History of bladder cancer.
History of macular edema.

A Trial of 18F-AV-133 Positron Emission Tomography (PET) Imaging to Differentiate Subjects With Parkinson's Disease (PD) From Other Movement Disorders

Purpose: The purpose of this study is to determine whether 18F-AV-133 PET scans can be used to differentiate subjects with Parkinson's Disease from other movement disorders.

Duration: 18 months

Study Design: Single-blind

Inclusion Criteria
Males or females ≥ 40 years of age.
Presenting for an initial evaluation to a movement disorders specialist with signs or symptoms suggestive of a movement disorder.
The subject's signs or symptoms were previously evaluated by a physician who was not a movement disorders specialist during the previous six months.
Absence of an established clinical movement disorder diagnosis.
Can tolerate imaging visit procedures.

Exclusion Criteria:
Have been referred to the movement disorders clinic primarily for the purpose of disease management (no diagnostic uncertainty exists on the part of the non-specialist or referring physician).
Have a previous movement disorder diagnosis given by a movement disorders specialist prior to the time of enrollment.
Have received a total of more than 60 days treatment with anti-parkinsonian medications.
Have had a sustained and clinically meaningful response to anti-parkinsonian medications.
Have a known CNS structural lesion such as stroke or tumor that likely accounts for their symptoms.
Have clinically meaningful cognitive impairment or dementia.
Have current clinically significant cardiovascular disease .
Have a current clinically significant endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer that would interfere with completion of the study.
Have a recent history (within the past year) of alcohol or substance abuse or dependence.
Have had prior intracranial surgery.

Disease-modifying Potential of Transdermal Nicotine in Early Parkinson's Disease (NIC-PD)

Purpose: The primary objective of this study is to demonstrate that transdermal nicotine treatment retards disease progression between baseline and after 52 weeks of study treatment plus two more months wash out (60 weeks).

Duration: 14 months

Study Design:  Randomized, Double-Blind, Placebo-Controlled

Inclusion Criteria:
Males or Females  ≥ 30 years
Early PD subjects within 18 months of diagnosis
Patients not receiving or needing dopamine agonist or levodopa therapy presently or for the next year
Stable treatment (>2 months) with MAO-B inhibitor (selegiline up to 10 mg/d or rasagiline up to 1 mg/d) allowable

Exclusion Criteria:
Clinical signs indicating a Parkinson syndrome other than idiopathic PD
History of nicotine use within five years of the baseline visit
Previous history of allergic response to nicotine application or any of the patch excipients
Previous history of allergic response to transdermal patches
Pre-existing dermatological disorder that could disturb transdermal patch application
Previous treatment with antiparkinsonian drugs (e.g. levodopa, dopamine agonists, etc.) other than MAO-B inhibitors
Suicide or suicide ideation
History of recent gastroduodenal ulcer (< 3 months) or presence of severe (acute and chronic) gastritis