Dopaminergic Enhancement of Learning and Memory in Healthy Adults and Patients With Dyslexia - Full Text View

Sponsored by:	University Hospital Muenster
Information provided by:	University Hospital Muenster
ClinicalTrials.gov Identifier:	NCT00111371

Purpose

This study aims to determine whether levodopa, in combination with a high frequency training of (grammatical) rules, is effective in boosting learning success in healthy subjects and whether this kind of training in combination with levodopa improves reading and spelling abilities of patients with dyslexia.

Condition	Intervention	Phase
Dyslexia	Drug: Levodopa	Phase IV

MedlinePlus related topics: Memory

Drug Information available for: Dopamine Dopamine hydrochloride Levodopa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Dopaminergic Enhancement of Learning and Memory (LL_001, Project on Dyslexia)

Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:

Boost in training success (percent correct) through levodopa as compared to placebo
Boost in training success (reaction times) through levodopa as compared to placebo
Increased performance on reading, spelling and writing tests in dyslexic patients treated with levodopa as compared to placebo

Secondary Outcome Measures:

Stability of improvements one month post training

Estimated Enrollment:	100
Study Start Date:	January 2005
Estimated Study Completion Date:	October 2007

Detailed Description:

Prior work by our group shows that d-amphetamine and the dopamine precursor levodopa markedly improve word learning success in healthy subjects. In this randomized, placebo-controlled, double-blind trial, we probe whether daily administration of levodopa, coupled with a training of grammatical rules, improves the training success in healthy adults as compared to placebo administration. In the second step of this study, patients with dyslexia will be trained with the identical protocol. We postulate that the combination of intensive training in language rules and levodopa improves the reading, writing, and spelling abilities of patients with dyslexia.

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Right-handedness
Age between 18-35 years
Primary language: German

Exclusion Criteria:

Known allergy to levodopa or tetrazine
History of medication/drug abuse
Acute nicotine withdrawal or > 10 cigarettes per day
>6 cups/glasses of coffee, caffeine drinks or energy drinks per day
>50 grams of alcohol per day
Hypertonia
Arteriosclerosis
Diabetes, asthma, or glaucoma
Psychiatric disease
Neurologic disease
Other medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111371

Contacts

Contact: Stefan Knecht, MD

+49-251-83 ext 48195

knecht@uni-muenster.de

Locations

Germany, North-Rhine Westphalia
Dept. of Neurology, University Hospital of Muenster	Recruiting
Muenster, North-Rhine Westphalia, Germany, 48129
Contact: Stefan Knecht, Prof. Dr. +49-251-83 ext 48195 knecht@uni-muenster.de
Principal Investigator: Stefan Knecht, M.D.

Sponsors and Collaborators

University Hospital Muenster

Investigators

Principal Investigator:

Stefan Knecht, Prof. Dr.

Dept. of Neurology, Universityclinic of Muenster

More Information

Publications:

Knecht S, Breitenstein C, Bushuven S, Wailke S, Kamping S, Floel A, Zwitserlood P, Ringelstein EB. Levodopa: faster and better word learning in normal humans. Ann Neurol. 2004 Jul;56(1):20-6.

Breitenstein C, Knecht S. [Language acquisition and statistical learning] Nervenarzt. 2003 Feb;74(2):133-43. Review. German.

Opitz B, Friederici AD. Brain correlates of language learning: the neuronal dissociation of rule-based versus similarity-based learning. J Neurosci. 2004 Sep 29;24(39):8436-40.

Study ID Numbers:	LL-001; Project on Dyslexia
Study First Received:	May 19, 2005
Last Updated:	April 18, 2007
ClinicalTrials.gov Identifier:	NCT00111371
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Muenster:

artificial grammar learning
dyslexia
healthy subjects
levodopa

drug
treatment
intervention

Study placed in the following topic categories:

Signs and Symptoms
Levodopa
Dopamine
Mental Disorders
Mental Disorders Diagnosed in Childhood
Neurologic Manifestations

Language Disorders
Dyslexia
Healthy
Learning Disorders
Neurobehavioral Manifestations
Communication Disorders

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs

Nervous System Diseases
Antiparkinson Agents
Dopamine Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009