Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2025-12-24 @ 10:16 PM
NCT ID:
NCT01190735
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01190735
Study Brief:
Protocol Section:
NCT01190735