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Dopaminergic Enhancement of Learning and Memory in Healthy Adults and Patients With Dementia/Mild Cognitive Impairment

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ClinicalTrials.gov Identifier: NCT00306124
Recruitment Status : Unknown
Verified October 2007 by University Hospital Muenster.
Recruitment status was:  Recruiting
First Posted : March 22, 2006
Last Update Posted : October 25, 2007
Sponsor:
Information provided by:
University Hospital Muenster

Brief Summary:

This study aims to determine whether levodopa is effective in boosting learning and memory in healthy subjects and patients with dementia or Mild Cognitive Impairment.

We also examine in healthy subjects using functional magnetic resonance imaging which brain regions mediate improved learning after levodopa administration.


Condition or disease Intervention/treatment Phase
Alzheimer's Disease Mild Cognitive Impairment Healthy Drug: Levodopa Phase 4

Detailed Description:
Prior work of our group shows that the dopamine precursor levodopa markedly improves word learning success in healthy subjects. In this randomized, placebo-controlled, double-blind trial, we probe whether administration of levodopa improves learning performance as compared to placebo administration on neuropsychological tests and in an associative learning paradigm. We postulate that levodopa improves learning success and memory performance in healthy subjects, while the effect in patients with dementia or Mild Cognitive Impairment might depend on other factors, including severity of memory impairment.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Dopaminergic Enhancement of Learning and Memory (LL_001, Project on Dementia/MCI)
Study Start Date : January 2006
Estimated Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia Memory
Drug Information available for: Levodopa
U.S. FDA Resources




Primary Outcome Measures :
  1. Cognitive performance assessed by neuropsychological tests and learning paradigms under placebo and levodopa in healthy subjects and patients with dementia or Mild Cognitive Impairment.
  2. Brain activity pattern during learning under levodopa as compared to placebo in healthy subjects.

Secondary Outcome Measures :
  1. Long-term stability of learning performance after 1 month in healthy subjects.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria for patients with dementia:

  • Patients: clinical diagnosis of AD or mild cognitive impairment
  • primary language German

Exclusion Criteria for healthy subjects and patients with dementia/MCI:

  • Known allergy to levodopa or tetrazine
  • History of medication/drug abuse
  • Acute nicotine withdrawal or > 15 cigarettes per day
  • > 6 cups/glasses of coffee, caffeine drinks or energy drinks per day
  • > 50 grams of alcohol per day
  • Severe hypertonia (systole >160 mm Hg)
  • Severe arteriosclerosis
  • Diabetes, asthma, or glaucoma
  • Severe hearing disability
  • no focal brain lesions
  • Premorbid depression or psychosis
  • Medication with dopamine agonists or antagonists
  • Parkinsonian symptoms

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00306124


Contacts
Contact: Bernward Winter, MSc +49-251-83 ext 45695 bwinter@uni-muenster.de

Locations
Germany
University of Muenster, Department of Neurology Recruiting
Muenster, North-Rhine Westphalia, Germany, 48129
Sponsors and Collaborators
University Hospital Muenster
Investigators
Principal Investigator: Stefan Knecht, MD Neurology, University of Muenster, Germany
Principal Investigator: Caterina Breitenstein, PhD Neurology, University of Muenster, Germany
Study Director: Julia Reinholz, PhD Neurology, University of Muenster, Germany

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00306124     History of Changes
Other Study ID Numbers: LL_001 Project on Dementia/MCI
First Posted: March 22, 2006    Key Record Dates
Last Update Posted: October 25, 2007
Last Verified: October 2007

Keywords provided by University Hospital Muenster:
Dementia
Mild Cognitive Impairment
MCI
levodopa
learning
enhancement

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Levodopa
Dopamine
Dopamine Agents
Dopamine Agonists
Antiparkinson Agents
Anti-Dyskinesia Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Protective Agents