Brain Energy Metabolism in Progressive Supranuclear Palsy: Comparison of PSP Patients and Healthy Controls and Effect of Coenzyme Q10 – nanoQuinon® - N/A

• Conditions: PSP is a sporadic neurodegenerative disorder resulting in a Parkinson syndrome with postural instability, oculomotor deficits, and cognitive decline. With an average annual incidence of 5.3 / 100000 and an age-adjusted prevalence of 6.4 / 100000, PSP is as common as motor-neuron disease. The progression of PSP is rapid and the median survival after onset of symptoms is 5-10 years. Presently, there is no known effective symptomatic or neuroprotective therapy for PSP.

• Registration Number: EUCTR2005-000574-40-DE
• Lead Sponsor: Kompetenznetz Parkinson e.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-24
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

·Subjects have a diagnosis of clinically probable PSP
·Subjects have early stage PSP: PSP staging system = III
·Subjects are capable and willing to give written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·Age > 85 years.
·Parkinson syndromes other than PSP (e.g. idiopathic Parkinson‘s disease, multiple system atrophy, diffuse Lewy body disease, FTDP17, symptomatic parkinsonism)
·Dementia [Mini Mental State Examination (MMSE) = 24]
·History of epilepsy, stroke, structural brain disease, brain surgery, or electroconvulsive therapy
·Arterial hypertension (systolic >180 or diastolic >110mm Hg)
·Diagnosis of systemic disorders affecting the metabolism or function of the brain (e.g. diabetes mellitus) unless sufficiently treated.
·Presence of other serious illnesses
·Insufficient contraception in male and pre-menopausal female participants.
·Participation in other drug studies within 30 days before baseline visit.
·Use of coenzyme Q10 within 60 days before baseline visit
·Use of any antioxidants (e.g. vitamin E, C) within 60 days before baseline visit
·Use of any drugs interfering with mitochondrial activity within 60 days before baseline visit
·Use of statins within 60 days before baseline visit (inhibit endogenous coenzyme Q10 production)
·Use of drugs interfering with catecholamine metabolism (e.g. reserpine, amphetamines, or monaomine oxidase-A inhibitors, methylphenidate, cinnarizine) within 30 days before baseline visit.
·Use of Levodopa within 30 days before baseline visit (coenzyme Q10 may change its metabolism).
·An unstable dosage of CNS-active drugs (e.g. anxiolytics, hypnotics, tranquillizer, antidepressants) within 30 days before baseline visit.
·An unstable dosage of other antiparkinsonian drugs within 30 days before baseline visit.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified