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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by University Hospital Muenster.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00306124
First received: March 21, 2006
Last updated: October 24, 2007
Last verified: October 2007
History of Changes
  Purpose

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 Intervention Phase
Alzheimer's Disease
Mild Cognitive Impairment
Healthy
 Drug: Levodopa
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Dopaminergic Enhancement of Learning and Memory (LL_001, Project on Dementia/MCI)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Muenster:

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

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

Estimated Enrollment: 120
Study Start Date: January 2006
Estimated Study Completion Date: March 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Dept. of Neurology, University of Muenster  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00306124     History of Changes
Other Study ID Numbers: LL_001 Project on Dementia/MCI
Study First Received: March 21, 2006
Last Updated: October 24, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on May 16, 2013