Predictive and Diagnostic Value of Tau and Beta-amyloid Markers in the Dementia of Parkinson's Disease

This is an interventional diagnostic trial for Parkinson's Disease focused on measuring Parkinson, dementia, FDDNP, tau, beta-amyloid Read More

Inclusion Criteria:

Inclusion Criteria PDD

• Male or female ≥ 60 years old;
• Diagnose of PD probable or definite according to criteria of the United Kingdom Parkinson's Disease Society Brain Bank;
• The Hoehn & Yahr stage of the disease between 3 and 5 in off state;
• Diagnose of dementia established according to the fourth edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and the diagnostic guidelines for dementia of the Movement Disorders Society (MDS);
• The score of the Mini-Mental State Examination of Folstein (MMSE) <24;
• The score on the Mattis Dementia Rating Scale (MDRS) <136.

Inclusion criteria PDND:

• Male or female ≥ 60 years old;
• Diagnose of PD probable or definite according to criteria of the United Kingdom Parkinson's Disease Society Brain Bank;
• The Hoehn & Yahr stage of the disease between 3 and 5 in OFF state;
• The score of the Mini-Mental State Examination of Folstein (MMSE) ≥24;
• The score on the Mattis Dementia Rating Scale (MDRS) ≥136.

Inclusion criteria Controls:

• Male or female ≥ 60 years old;
• No known diagnosis of neuropsychiatric diseases
• The score of the Mini-Mental State Examination of Folstein (MMSE) ≥24;
• The score on the Mattis Dementia Rating Scale (MDRS) ≥136.

Exclusion Criteria:

• The subject is pregnant or breastfeeding;
• The subject has a history of drug abuse or alcohol;
• The subject has developed dementia in the first year of parkinsonism or before than parkinsonism;
• The subject meets criteria for vascular dementia;
• The subject has symptoms suggestive of other types of parkinsonism (multi-system atrophy cortico-basal, supra-nuclear palsy progressive degeneration) or degenerative dementia (fronto-temporal dementia);
• The subject has a moderate or severe renal functional impairment (serum creatinine> 1.5 mg / dL);
• The subject has a moderate or severe hepatic impairment (bilirubin> 2 times the upper limit of normal, transaminases> 3 times the upper limit of normal);
• The subject presents structural abnormalities in basal ganglia or cortical level on magnetic resonance imaging or computerized tomography;
• The subject has participated in a clinical study with an investigational drug product within 30 days prior to screening and / or radiopharmaceutical in a minimum period of 5 radioactive half-lives prior to screening;
• Occupational exposure to radiation> 15 milliSievert (mSv) / year
• The subject has received treatment with non-steroidal anti-inflammatory drugs during the 30-day period before the PET scan
• The subject has allergy to the investigational product or any of its components;
• The subject has a clinically active, serious disease with a reduced life expectancy;
• The subject is claustrophobic / a.
• The subject has received in the last 364 days a dose of ionizing radiation that coupled with the study dose exceeds 10 mSv