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

NCT ID: NCT00111371

Last Updated: 2014-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2015-10-31

Brief Summary

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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

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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.

Conditions

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Dyslexia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Levodopa

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Muenster

OTHER

Sponsor Role lead

Principal Investigators

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Stefan Knecht, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Dept. of Neurology, Universityclinic of Muenster

Locations

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Dept. of Neurology, University Hospital of Muenster

Münster, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Stefan Knecht, MD

Role: CONTACT

[email protected]
+49-251-83 ext. 48195

Facility Contacts

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Stefan Knecht, Prof. Dr.

Role: primary

[email protected]
+49-251-83 ext. 48195

References

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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.

Reference Type BACKGROUND
PMID: 15236398 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 12596014 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15456816 (View on PubMed)

Other Identifiers

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LL-001; Project on Dyslexia

Identifier Type: -

Identifier Source: org_study_id