Caffeine for Motor Manifestations of Parkinson's Disease

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Numerous epidemiological studies have linked lifelong use of caffeine to a lower risk of Parkinson's disease (PD) - prospective studies have estimated that non-coffee drinkers have an approximately 1.7-2.5 fold increased risk of developing PD compared to coffee drinkers. This is an extremely important finding which deserves further more in depth investigations.

The exact pathophysiological mechanism remains elusive, but multiple hypotheses do exist:

Caffeine antagonizes adenosine receptors directly yielding an improvement on motor systems and even on Levodopa serum concentrations (when on therapy). An additional explanation is that adenosine antagonism has neuroprotective properties by acting locally on basal ganglia circuits and the substantia nigra.

The current study aims to identify the optimal caffeine dose with maximal motor benefit and the least amount of undesirable adverse effects.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ron Postuma
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Treatments: Caffeine; Central Nervous System Stimulants; Molecular Mechanisms of Pharmacological Action

Criteria

Inclusion Criteria:

1. Subject has been diagnosed with idiopathic Parkinson's disease (stage I - IV Hoehn and Yahr)

Exclusion Criteria:

1. Estimated daily caffeine intake of more than 200 mg per day.

2. Subject has dementia (MMSE < 26/30) and ADL impairment secondary to cognitive loss, inability to understand consent process.

3. Changes to antiparkinsonian medications in last 4 weeks or changes will be required during the period of the study protocol.

4. Contraindication to caffeine use:

1. Uncontrolled hypertension (systolic bp >170 or diastolic bp >110 on two consecutive readings)

2. Use of lithium or clozapine

3. Pre-menopausal women who are not using effective methods of birth control

4. Current use of prescribed alerting agents such as modafinil and methylphenidate

5. Active peptic ulcer disease

6. Supraventricular cardiac arrhythmia

7. Previous adverse reaction to caffeine which either required admission to hospital,or after which the patient was directly advised by a physician to not use caffeine.