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

Study Overview
=================
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.

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

Conditions
-----------------
Dyslexia

Intervention / Treatment
-----------------
* Drug: Levodopa


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levodopa|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stability of improvements one month post training |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
artificial grammar learning, dyslexia, healthy subjects, levodopa, drug, treatment, intervention