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

NCT00111371 | Unknown Phase 4

• 1 other identifier: LL-001; Project on Dyslexia
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dyslexia

Keywords

artificial grammar learning; dyslexia; healthy subjects; levodopa; drug; treatment; intervention

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Stability of improvements one month post training

Interventions

Levodopa DRUG

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

Dept. of Neurology, University Hospital of Muenster

Münster, North Rhine-Westphalia, 48129, Germany

RECRUITING

Related Publications (3)

• 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.

  PMID: 15236398 BACKGROUND

• Breitenstein C, Knecht S. [Language acquisition and statistical learning]. Nervenarzt. 2003 Feb;74(2):133-43. doi: 10.1007/s00115-002-1466-1. German.

  PMID: 12596014 BACKGROUND

• 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.

  PMID: 15456816 BACKGROUND

MeSH Terms

Conditions

Dyslexia

Interventions

Levodopa

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Specific Learning Disorder; Learning Disabilities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine

Study Officials

• Stefan Knecht, Prof. Dr.

  Dept. of Neurology, Universityclinic of Muenster

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Knecht, MD

CONTACT

+49-251-83; knecht@uni-muenster.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 19, 2005
• First Posted: May 20, 2005
• Study Start: January 1, 2005
• Study Completion: October 1, 2015
• Last Updated: December 5, 2014

Record last verified: 2006-09

Locations

DE (1)