Dopaminergic Enhancement of Learning and Memory in Healthy Adults and Patients With Dyslexia

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2006 by University Hospital Muenster. Recruitment status was Recruiting

First Received on May 19, 2005. Last Updated on April 18, 2007 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Memory

Drug Information available for: Dopamine Levodopa Dopamine hydrochloride

U.S. FDA Resources

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
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.

ClinicalTrials.gov Identifier:	NCT00111371 History of Changes
Other Study ID Numbers:	LL-001; Project on Dyslexia
Study First Received:	May 19, 2005
Last Updated:	April 18, 2007
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

Additional relevant MeSH terms:

Dyslexia
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Learning Disorders
Signs and Symptoms
Mental Disorders Diagnosed in Childhood
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 February 12, 2012