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

Tracking Information

First Received Date ^ICMJE

May 19, 2005

Last Updated Date

April 18, 2007

Start Date ^ICMJE

January 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00111371 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Stability of improvements one month post training

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Dyslexia

Intervention ^ICMJE

Drug: Levodopa

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

100

Estimated Completion Date

October 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Stefan Knecht, MD

+49-251-83 ext 48195

knecht@uni-muenster.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00111371

Responsible Party

Study ID Numbers ^ICMJE

LL-001; Project on Dyslexia

Study Sponsor ^ICMJE

University Hospital Muenster

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Stefan Knecht, Prof. Dr.

Dept. of Neurology, Universityclinic of Muenster

Information Provided By

University Hospital Muenster

Verification Date

September 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP