Clinical trial NCT00111371: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dyslexia
Keywords: artificial grammar learning
dyslexia
healthy subjects
levodopa
drug
treatment
intervention
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2005-05-20
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Boost in training success (percent correct) through levodopa as compared to placebo
measure: Boost in training success (reaction times) through levodopa as compared to placebo
measure: Increased performance on reading, spelling and writing tests in dyslexic patients treated with levodopa as compared to placebo
Secondary outcomes:
measure: Stability of improvements one month post training
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Dept. of Neurology, University Hospital of Muenster
state: North-Rhine Westphalia
Study officials:
affiliation: Dept. of Neurology, Universityclinic of Muenster
name: Stefan Knecht, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.