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

Dopaminergic Enhancement of Learning and Memory (LL_001, Project on Dyslexia)

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.

Study Overview

• Status: Unknown
• Conditions: Dyslexia
• Intervention / Treatment: Drug: Levodopa

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Stability of improvements one month post training

Collaborators and Investigators

• Sponsor: University Hospital Muenster
• Investigators: Principal Investigator: Stefan Knecht, Prof. Dr., Dept. of Neurology, Universityclinic of Muenster

Publications and helpful links

General 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. doi: 10.1002/ana.20125.
• Breitenstein C, Knecht S. [Language acquisition and statistical learning]. Nervenarzt. 2003 Feb;74(2):133-43. doi: 10.1007/s00115-002-1466-1. 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. doi: 10.1523/JNEUROSCI.2220-04.2004.

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion: December 7, 2022
• Study Completion (Anticipated): October 1, 2015

Study Registration Dates

• First Submitted: May 19, 2005
• First Submitted That Met QC Criteria: May 19, 2005
• First Posted (Estimate): May 20, 2005

Study Record Updates

• Last Update Posted (Estimate): December 5, 2014
• Last Update Submitted That Met QC Criteria: December 4, 2014
• Last Verified: September 1, 2006

More Information

Terms related to this study

• Keywords: treatment; intervention; artificial grammar learning; dyslexia; healthy subjects; levodopa; drug
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Language Disorders; Communication Disorders; Learning Disabilities; Dyslexia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Levodopa
• Other Study ID Numbers: LL-001; Project on Dyslexia

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No