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

Dyslexia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00111371
• Other study ID #: LL-001; Project on Dyslexia
• Status: Recruiting
• Phase: Phase 4
• First received: May 19, 2005
• Last updated: December 4, 2014
• Start date: January 2005
• Est. completion date: October 2015

Study information

• Verified date: September 2006
• Source: University Hospital Muenster
• Contact: Stefan Knecht, MD
• Phone: +49-251-83
• Email: knecht[@]uni-muenster.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslexia

Intervention

Drug:
• Levodopa

Locations

Country	Name	City	State
Germany	Dept. of Neurology, University Hospital of Muenster	Muenster	North-Rhine Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boost in training success (percent correct) through levodopa as compared to placebo
Primary	Boost in training success (reaction times) through levodopa as compared to placebo
Primary	Increased performance on reading, spelling and writing tests in dyslexic patients treated with levodopa as compared to placebo
Secondary	Stability of improvements one month post training