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Status:

COMPLETED

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

Lead Sponsor:

Fundacion Clinic per a la Recerca Biomédica

Conditions:

Parkinson's Disease

Parkinson-Dementia Syndrome

Eligibility:

All Genders

60+ years

Phase:

EARLY_PHASE1

Brief Summary

The PET tracer Fluoro-ethyl-methyl-amino-naphthyl-ethylidene-malononitrile (\[F18\]-FDDNP) has a specific affinity for lesions containing tau protein and beta-amyloid The study consists of two phases ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2012

Estimated Enrollment :

28 Patients enrolled

Trial Details

Trial ID

NCT02243982

Start Date

March 1 2010

End Date

December 1 2012

Last Update

September 18 2014

Active Locations (1)

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1

Hospital Clinic

Barcelona, Barcelona, Spain, 08036