icotinamide,vitamin B3, metabolic pathways in patients with early idiopathic parkinson's disease

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

ŸMen and women with Idiopathic Parkinson’s Disease within 2 years of presentation.( early stage of the disease)
ŸPresence of at least two symptoms (resting tremor, bradykinesia, rigidity) which
are asymmetric.( main criteria of diagnosis for Parkinson’s disease)
ŸWomen must be either postmenopausal, sterilized or be on a contraceptive regime
for at least two months prior the randomization.( Nicotinamide dose more than 40 mgs is not recommended in pregnancy)
ŸAge > 40 years.( excluding early presentation of familiar Parkinson’s disease)
ŸWilling and able to give written consent.
ŸWilling to comply with the trial’s requirements.( essential )
ŸSubjects on monotherapy treatment only with or without dopamine agonists for no longer than two years prior to enrollment.( indicating early stage)

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

ŸUse of any food supplements with Nicotinamide longer than three months prior to
enrollment.( otherwise will bias the baseline values)
ŸUse of centrally acting drugs Methyldopa and Monoxidine.( interference with Nicotinamide metabolism in the brain)
ŸPatients with pancreatic insufficiency.( due to impaired vitamin absorption)
ŸPatients with hepatic dysfunction of any cause.( unpredictable and unsafe metabolism of Nicotinamide)
ŸUse of drugs interfering with mitochondria function such as Methylphenidate.
(due to antagonism for site of action with Nicotinamide)
ŸUnder a variable drug dosage regime with effect on central nervous system such as, anxiolytics, hypnotics, and antidepressants. (unpredictable interactions with Nicotinamide)
ŸPatients with drug induced Parkinson’s disease.
ŸThe presence of dementia with a Mini Mental Test score of less than 20.(alternative diagnosis or late stage of disease)
ŸPresence of severe depression with Hamilton Depression Scale of more than 10 ( no available data of safety of Nicotinamide in severely depressed patients)
ŸA modified Hoehn and Yahr score of more than 2.0.( indicator of late stage)
ŸThe use of appetite suppressants or weight lowering medication, such as Xenical
(Orlistat) or Reductil (Sibutramine).( central interaction of these drugs)
ŸA history of more than two Transient Ischaemic Attacks and or Strokes. (indicating vascular etiology of the disease)
ŸActive Epilepsy.( no data in safety using Nicotinamide above daily recommended dosage which is 40mgs)
ŸActive Peptic Ulcer Disease. (Nicotinamide might worsen the ulcer)
ŸThe presence of serious disorders such as; unstable angina, Heart Failure, Severe Chronic Obstructive Pulmonary Disease (COPD), Renal Failure and any chronic
debilitating disorders.( unpredictable Nicotinamide metabolism and energy
requirements for each subject)
ŸAny active Psychiatric disorder.( not able to give consent)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Main objective : measurement of N-Methyl-Nicotinamide in urine and ATP Complex I in blood of patients with early Parkinson’s disease and non Parkinson’s patients;Secondary Objective: NONE;Primary end point(s): N-Methyl Nicotinamide levels in urine and ATP complex I in blood measurements

Secondary Outcome Measures