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Parkinson's DiseasePhase 3NCT01738178

Caffeine as a Therapy for Parkinson's Disease

A Phase 3 study testing Caffeine in people with Parkinson's Disease, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Parkinson's disease is a common neurodegenerative disorder in which patients experience progressive motor disability and many disabling non-motor symptoms. Recent studies have consistently found that people who do not use caffeine are at higher risk of developing Parkinson's disease. Read more about this study

Who is it for?
Ages 45 to 75 years
Conditions the study is for
Parkinson's Disease
What is being tested?
Caffeine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
119 participants
Where
8 sitesin 2 countries
Study dates
Apr 2014to 1 Dec 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients must have idiopathic PD diagnosed as parkinsonism according to the UK brain bank criteria, and PD considered the likeliest underlying cause according to the treating physician. Other inclusion criteria include:
  • PD diagnosis: between 6 months and 8 years
  • Hoehn and Yahr stage I-III
  • Age at least 45 and less than 75 (to optimize survival over the 5-year trial).
  • Receiving symptomatic therapy for PD for at least 6 months. Dose must have been stable over the previous 3 months.

Who cannot join

  • Caffeine intake >150 mg per day (i.e. more than one cup of filtered coffee per day) or prescribed adenosine antagonists - caffeine intake will be measured by a standardized intake questionnaire. Intake will be converted into estimated caffeine mg dose by standard caffeine-content charts.
  • Active peptic ulcer disease, or symptomatic gastroesophageal reflux disease.
  • Supraventricular cardiac arrhythmia (such as atrial fibrillation or atrial flutter) - Electrocardiogram will be measured at baseline to rule out supraventricular tachycardia.
  • Uncontrolled hypertension - systolic bp >170 or diastolic bp >110 on two readings.
  • Pre-menopausal women who are not using effective methods of birth control
  • Cognitive impairment, defined as MoCA <23/30.
Show all 9Show fewer
  • Moderate-Severe Depression, as defined by a Beck Depression Inventory score of >19.
  • Changes to antiparkinsonian medication in the last 3 months, or changes to antiparkinsonian medication are anticipated during the next six months.
  • Current use of lithium or clozapine (pharmacokinetic interactions).

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

Canada7 sites

  • Heritage Medical Research Clinic - University of Calgary

    Calgary, Alberta, T2N 4Z6

  • McGill University Health Center

    Montreal, Quebec, H3G 1A4

  • The Ottawa Hospital - Civic Campus

    Ottawa, Ontario, K1Y 4E9

  • Memorial University of Newfoundland

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Toronto western Hospital - Movement Disorders Research Centre

    Toronto, Ontario, M5T 2S8

  • UBC Hospital - Pacific Parkinson's Research Centre

    Vancouver, British Columbia, V6T 2B5

  • Movement Disorder Clinic - Deer Lodge Centre

    Winnipeg, Manitoba, R3J 2H7

Other trials in Canada

Brazil1 site

  • Parana Parkinson Association - Pontifical Catholic University of Parana

    Curitiba, Paraná, 80240-021

Other trials in Brazil

About this study

Official title: Caffeine as a Therapeutic Agent in Parkinson's Disease

Parkinson's disease is a common neurodegenerative disorder in which patients experience progressive motor disability and many disabling non-motor symptoms. Recent studies have consistently found that people who do not use caffeine are at higher risk of developing Parkinson's disease. This suggests that caffeine may have potential as a treatment for PD.

In a pilot study of caffeine for daytime sleepiness in PD, there was evident benefit on the motor manifestations of disease. There have been other lines of evidence that have suggested caffeine could be useful in PD. This study is to evaluate the efficacy of caffeine 200 mg BID vs matching placebo for motor and non-motor aspects of disease. This will be in three stages. In the first six-month stage, medications will be held constant, to see whether caffeine does have motor benefits. Then we will perform a four-year extension stage to define if the effects of caffeine persist (or even magnify), and to see if caffeine helps reduce dose of other PD meds and/or prevents their side effects. Finally, we will finish with a six-month stage in which we will place all patients on caffeine - this will allow us to assess caffeine's use in later disease, but more importantly, will assess whether early use of caffeine produces long term changes beyond its immediate effects.

Being tested
Caffeine, Placebo
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01738178
Study groupRoleWhat they receive
Control - PlaceboPlacebo comparatorThese participants will receive placebo tablets during the first 5 years
Receives: Drug: Placebo
Caffeine groupActive comparatorThis group of participants will receive caffeine tablets.
Receives: Drug: Caffeine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Motor manifestations associated with Parkinson's disease

    For each stage of the study, the MDS-Unified Parkinson Disease Rating Scale (MDS-UPDRS)will be used as the primary outcome. The MDS-UPDRS is the standard scale used for grading severity of PD - its revised 2008 version has more standardized motor assessment, better sensitivity to change in early-mid stages, and a broader assessment of non-motor PD. It starts with a patient self-administered questionnaire covering activities of daily living, motor symptoms, and non-motor domains. There is then a scored clinical interview assessing cognitive and psychiatric symptoms and motor complications. The Hoehn and Yahr scale (5-point overall disease severity index) is included3. Finally, there is a formal examination component (Part III) (performed in the medication 'on' state for this study).

    Measured: every 6 months

Secondary outcomes (6)

  1. MDS-UPDRS components and subscales - each individual component will be assessed, including:

    1. motor symptoms, according to each subscale question. These include speech deficits, swallowing dysfunction, motor activities of daily living (dressing, feeding, turns in bed, etc), tremor, gait slowing, freezing, and falls
    2. non-motor symptoms, according to each subscale question. These include constipation, urinary dysfunction, sexual dysfunction, orthostatic symptoms, depression, anxiety, cognitive symptoms, apathy, somnolence, insomnia, pain, and fatigue.
    3. motor complications - motor fluctuations and dyskinesia
    4. Hoehn and Yahr staging (a five-point global staging system for PD).

    Measured: every 6 months

  2. Cognition

    Although cognitive symptoms are addressed with the UPRDS, we will include two objective measures, the Montreal Cognitive Assessment (MoCA), and Mini-mental State Examination. The MoCA is a brief cognitive test, which is used extensively in PD. The MMSE will be used in diagnosis of dementia. Dementia will be assessed according to Level I MDS criteria. ADL impairment due to cognitive loss will be documented according to MDS criteria.

    Measured: every 6 months

  3. Sleep

    Because caffeine may have special effectiveness for sleep disorders, we will include additional sleep questionnaires, including

    1. the SCOPA-sleep8 nighttime scale.
    2. the SCOPA-sleep8 daytime scale
    3. the REM sleep behavior disorder single-question screen (RBD1Q)

    Measured: every 6 motnhs

  4. Quality of life

    The Parkinson's Disease Questionnaire-8 is a quality of life index for PD with 8 self-administered items assessing motor function, gait, mood, cognition, etc.

    Measured: every 6 months

  5. Medication utilization

    To assess caffeine's potential medication-sparing benefit, we will quantify all medications at each visit. Levodopa-dose equivalents will be calculated with standard criteria. Total medication cost will be calculated using current Canadian pharmacy pricing.

    Measured: evry 6 months

  6. Tolerability and side effects of caffeine

    A structured questionnaire will screen for irritability, symptoms of gastrointestinal reflux, diarrhea, sleepiness, palpitations, sweating, and tremulousness. In addition, open-ended questions will allow reporting of other side effects. Blood pressure will be measured at each visit to exclude new-onset hypertension, and orthostatic hypotension will be objective assessed with blood pressure measurements lying and standing (1 minute).

    Measured: every 6 motnhs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2012 (estimated)
  2. Study startApr 2014
  3. Primary completion1 May 2016
  4. Study completion1 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01738178
Sponsor's protocol ID
2778
Status last verified
Mar 2017
First submitted
28 Nov 2012
Last updated
22 Mar 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Postuma RB, Anang J, Pelletier A, Joseph L, Moscovich M, Grimes D, Furtado S, Munhoz RP, Appel-Cresswell S, Moro A, Borys A, Hobson D, Lang AE. Caffeine as symptomatic treatment for Parkinson disease (Cafe-PD): A randomized trial. Neurology. 2017 Oct 24;89(17):1795-1803. doi: 10.1212/WNL.0000000000004568. Epub 2017 Sep 27.

    PubMed 28954882

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Caffeine in people with Parkinson's Disease, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Canada, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Motor manifestations associated with Parkinson's disease (time frame: every 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01738178, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2017.

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