Back to results

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

Primary Purpose

Dyslexia

Status

Unknown status

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Levodopa

About this trial

This is an interventional treatment trial for Dyslexia focused on measuring artificial grammar learning, dyslexia, healthy subjects, levodopa, drug, treatment, intervention

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Dept. of Neurology, University Hospital of MuensterRecruiting

Outcomes

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

Full Information

NCT ID

NCT00111371

First Posted

May 19, 2005

Last Updated

December 4, 2014

Sponsor

University Hospital Muenster

1. Study Identification

Unique Protocol Identification Number

NCT00111371

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2006

Overall Recruitment Status

Unknown status

Study Start Date

January 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital Muenster

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyslexia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Levodopa

Primary Outcome Measure Information:

Title

Boost in training success (percent correct) through levodopa as compared to placebo

Title

Boost in training success (reaction times) through levodopa as compared to placebo

Title

Increased performance on reading, spelling and writing tests in dyslexic patients treated with levodopa as compared to placebo

Secondary Outcome Measure Information:

Title

Stability of improvements one month post training

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Stefan Knecht, MD

Phone

+49-251-83

Ext

48195

knecht@uni-muenster.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stefan Knecht, Prof. Dr.

Organizational Affiliation

Dept. of Neurology, Universityclinic of Muenster

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dept. of Neurology, University Hospital of Muenster

City

Muenster

State/Province

North-Rhine Westphalia

ZIP/Postal Code

48129

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stefan Knecht, Prof. Dr.

Phone

+49-251-83

Ext

48195

knecht@uni-muenster.de

First Name & Middle Initial & Last Name & Degree

Stefan Knecht, M.D.

12. IPD Sharing Statement

Citations:

PubMed Identifier

15236398

Citation

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.

Results Reference

background

PubMed Identifier

12596014

Citation

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

Results Reference

background

PubMed Identifier

15456816

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. doi: 10.1523/JNEUROSCI.2220-04.2004.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs