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

Sponsor
University Hospital Muenster (Other)
Overall Status
Unknown status
CT.gov ID
NCT00111371
Collaborator
(none)
100
1
129
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Dopaminergic Enhancement of Learning and Memory (LL_001, Project on Dyslexia)
Study Start Date :
Jan 1, 2005
Anticipated Study Completion Date :
Oct 1, 2015

Outcome Measures

Primary Outcome Measures

  1. Boost in training success (percent correct) through levodopa as compared to placebo []

  2. Boost in training success (reaction times) through levodopa as compared to placebo []

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

Secondary Outcome Measures

  1. Stability of improvements one month post training []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dept. of Neurology, University Hospital of Muenster Muenster North-Rhine Westphalia Germany 48129

Sponsors and Collaborators

  • University Hospital Muenster

Investigators

  • Principal Investigator: Stefan Knecht, Prof. Dr., Dept. of Neurology, Universityclinic of Muenster

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00111371
Other Study ID Numbers:
  • LL-001; Project on Dyslexia
First Posted:
May 20, 2005
Last Update Posted:
Dec 5, 2014
Last Verified:
Sep 1, 2006
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 5, 2014