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Archive for June, 2007

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This study is currently recruiting patients

Monday, June 4th, 2007

Verified by Boehringer Ingelheim Pharmaceuticals May 2007

Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00349310

Purpose

To explore or establish the relationship between cognitive, mood and motor symptoms in PD to scores on depression rating scales in a naturalistic setting.

Condition Intervention Phase
Parkinson Disease
Depression		  Drug: Pramipexole Phase IV

MedlinePlus related topics:  Depression;   Parkinson’s Disease
Genetics Home Reference related topics:  Parkinson disease

Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Official Title: Profile of Depressive Symptoms in Parkinson’s Disease

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures: 

  • HADS, HAMD-17, BDI-1A, FAB (cognitive), DSM-IV (mood- part A, B, C, E) and UPDRS

Total Enrollment:  1018

Study start: April 2006;  Expected completion: October 2006

This is a multi-national, multicenter, prospective observational study in which 8 European countries participate. Patients with idiopathic PD as defined by the criteria of the United Kingdom Parkinsons Disease Society Brain Bank (UK-PDS-BB) and a score on the Mini Mental State Examination (MMSE) of ?24 are included. The UPDRS is used to quantify ADL function, motor symptoms, and complications of therapy. Depression is diagnosed according to the DSM IV criteria. The depression rating scales used are the Hospital Anxiety and Depression rating Scale (HADS), the Hamilton Depression Rating Scale (HAMD-17), and the Beck Depression Inventory (BDI-1A). The Frontal Assessment Battery (FAB) is used to assess frontal function. The target patient number in this study will be 1000 patients with an inclusion period of 6 months.

Study Hypothesis:

Comparison(s):

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion_Criteria:

Observation criteria:

are able to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation have idiopathic Parkinsons disease according to the United Kingdom Parkinsons Disease Society Brain Bank Diagnostic Criteria for Parkinsons disease show no impairment of cognitive function (MMSE score ?24) are with or without symptoms of depression (full range) are stable on anti-Parkinson/anti-depressive treatment for at least 1 month before entering the study are or are not on concomitant antidepressant Tx are in the on state during the observation period did not previously undergo PD surgery

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00349310

Boehringer Ingelheim Study Coordinator       clintriage@rdg.boehringer-ingelheim.com

Austria
      Boehringer Ingelheim Investigational Site, Innsbruck,  6020,  Austria; Completed
      Boehringer Ingelheim Investigational Site, Wien,  1130,  Austria; Completed
      Boehringer Ingelheim Investigational Site, Wien,  1090,  Austria; Completed
France
      Hôpital Purpan, Toulouse cedex,  31073,  France; Completed
      Hôpital Rangueil, Toulouse cedex 9,  31059,  France; No longer recruiting
Germany
      Universitätsklinikum Carl Gustav Carus Dresden, Dresden,  01307,  Germany; Completed
      Boehringer Ingelheim Investigational Site, Gera,  07551,  Germany; Completed
      Gertrudis-Kliniken Biskirchen, Leun,  35638,  Germany; Completed
      Parkinson Klinik Wolfach, Wolfach,  77709,  Germany; Completed
      Neurologisches Fachkrankenhaus für, Beelitz-Heilstätten,  14547,  Germany; Completed
      Boehringer Ingelheim Investigational Site, Unterhaching,  82008,  Germany; Completed
Italy
      Università Federico II, NAPOLI,  80131,  Italy; Completed
      Azienda Ospedaliera S. Martino, GENOVA,  16100,  Italy; Completed
      Università La Sapienza di Roma, ROMA,  00161,  Italy; Completed
      Policlinico di Catania, CATANIA,  95125,  Italy; Completed
Netherlands
      Academisch Ziekenhuis Maastricht, Maastricht,  6229 HX,  Netherlands; Completed
Spain
      Hospital Clinic i Provincial. Neurology, Barcelona,  08036,  Spain; Completed
      Hospital de Cruces. Neurology, Baracaldo / Bilbao,  48903,  Spain; Completed
      Hospital Puerta del Mar. Neurology, Cadiz,  11519,  Spain; Completed
Switzerland
      Clinica Hildebrand, Brissago,  6614,  Switzerland; Recruiting
      Hôpital Cantonal (HUG), Genève,  1211,  Switzerland; Recruiting
      Kantonsspital St. Gallen, St.Gallen,  9007,  Switzerland; Recruiting
United Kingdom
      Boehringer Ingelheim Investigational Site, London,  NW3 2QG,  United Kingdom; Completed
      Boehringer Ingelheim Investigational Site, Newark,  NG24 4DE,  United Kingdom; Completed
 

Study chairs or principal investigators

Boehringer Ingelheim Study Coordinator,  Study Chair,  Boehringer Ingelheim BV/Alkmaar   

More Information

Study ID Numbers:  248.597
Last Updated:  May 25, 2007
Record first received:  July 5, 2006
ClinicalTrials.gov Identifier:  NCT00349310

Posted in Clinical Trial, General | No Comments »

Is Parkinson’s Disease Hereditary?

Saturday, June 2nd, 2007

Causes

Date updated: May 4, 2007
Content provided by MayoClinic.com In the nearly 200 years since Parkinson’s disease was first described, researchers have come to understand some of the processes of this complex disorder.

They now know that many of the signs and symptoms of Parkinson’s disease develop when certain nerve cells (neurons) in an area of the brain called the substantia nigra are damaged or destroyed. Normally, these nerve cells release dopamine – a chemical that transmits signals between the substantia nigra and another part of the brain, the corpus striatum. These signals cause your muscles to make smooth, controlled movements.

Everyone loses some dopamine-producing neurons as a normal part of aging. But people with Parkinson’s disease lose half or more of neurons in the substantia nigra. Although other brain cells also degenerate, the dopamine-containing cells are critical for movement and so take center stage. Just what causes this is a subject of intense research. Scientists believe Parkinson’s disease may result from a combination of genetic and environmental factors. Certain drugs, diseases and toxins also may cause symptoms similar to those of Parkinson’s disease.

Genetic factors
Scientists believe that genes contribute to the development of Parkinson’s, but it’s not yet clear whether heredity plays a major or minor role in this disease.

It has been known for some time that people with a first-degree relative with Parkinson’s disease, such as a parent, child or sibling, are more likely to develop the disease than are people without a family connection. Although the risk among first-degree relatives is small – less than 5 percent – it nevertheless suggests a genetic link. For that reason, scientists have focused on the rare families in which several people have Parkinson’s – and that research has provided insights into the cause of the disease in general.

In families with Parkinson’s, researchers have identified two types of genetic causes. One involves abnormalities of alpha-synuclein, a protein that accumulates in degenerating neurons in people with Parkinson’s. The other involves problems with the systems in the body that dispose of unwanted proteins. It now appears that both of these factors play a key role in the development of Parkinson’s in all people.

Environmental factors
People with unusual exposure to herbicides and pesticides are more likely to develop Parkinson’s disease than are people who don’t have this exposure. Researchers haven’t yet been able to connect a specific herbicide or pesticide to the disease.

Medications
A number of drugs taken for long periods of time or in excessive dosages can cause symptoms of Parkinson’s disease. These include medications such as haloperidol (Haldol) and chlorpromazine (Thorazine), which are prescribed for certain psychiatric disorders, as well as drugs used to treat nausea, such as metoclopramide (Reglan, Metoclopramide HCL). The epilepsy drug valproate (Depakene) also may cause some of the features of parkinsonism, especially severe tremor.

These medications do not cause Parkinson’s disease, however, and symptoms disappear when the drugs are stopped.

Posted in General, Research | No Comments »

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