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Completed

NCT Number: NCT00215904

D-serine Adjuvant Treatment for Parkinson's Disease

The proposed experiment will evaluate the effects of the NMDA receptor full agonist D-serine (~2g/day) on persistent symptoms of Parkinson's Disease and on antiparkinsonian drugs-induced dyskinesias.

D-serine will be used as add-on therapy to on-going medications received by Parkinson's Disease patients. The rational for this study stems from observations made in pervious clinical trials with schizophrenia patients, in which it was demonstrated that D-serine adjuvant treatment resulted in:1)improvement of parkinsonian side effects induced by antipsychotic drugs and 2) improvement of depression and negative (i.e apathy, blunted effects, anhedonia) symptoms which are similar to symptoms encountered in Parkinson's Disease.

The study will have a crossover design in accordance to which each patient will receive, in random order D-serine and placebo for a 6 weeks period each. Thus, any participant will have the opportunity to receive the experimental treatment.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ezrath Nashim - Herzog Memorial Hospital

Jerusalem, 91351, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • PD diagnosis
  • ≥2 on UPDRS items 32,33
  • receive treatment with L-dopa alone or in combination with other antiparkinsonian medications.

Exclusion criteria

  • current or previous history of other neurological disorders
  • unstable medical conditions
  • renal pathology
  • pregnant female patients excluded

Treatment and study plan

D-serine (~2g/day)

Drug

Two 6 weeks treatment arms. One arm: adjuvant treatment with D-serine (~2g/day). Second arm : adjuvant treatment with placebo (~2g/day).

Primary outcomes

  1. UPDRS scores

    Time frame: 6 weeks

  2. PANSS scores

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Herzog Hospital

Other

Registry information

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Sep 22, 2005
Registry last updated
Jul 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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