NCT00102856

Brief Summary

The purpose of this study is to determine whether rivastigmine or pramipexol are effective in boosting semantic language acquisition in healthy subjects.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
60

participants targeted

Target at P50-P75 for phase_4 healthy

Timeline
Completed

Started Jan 2005

Typical duration for phase_4 healthy

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

June 24, 2010

Status Verified

September 1, 2006

First QC Date

February 3, 2005

Last Update Submit

June 23, 2010

Conditions

Healthy

Keywords

language acquisitionplasticitystroke recoveryassociative learning

Outcome Measures

Primary Outcomes (1)

  • Boost in language learning success (percent hits) through neuromodulation

Secondary Outcomes (1)

  • Stability of language learning success after one week, one month, and one year

Interventions

PramipexoleDRUG
RivastigmineDRUG

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects
  • years old
  • Right handedness
  • Left language dominance (as assessed by functional transcranial Doppler ultrasonography \[fTCD\])

You may not qualify if:

  • Neurological/psychiatric/metabolic/cardiac disorders
  • Asthma
  • Known allergic reactions to one of the experimental drugs
  • Other drugs affecting the central nervous system
  • Leisure drug ingestion during the past 4 weeks (urine test)
  • Smoking cessation during the past 2 weeks
  • \> 6 cups of coffee or energy drinks per day
  • \> 10 cigarettes per day
  • \> 50 grams of alcohol per day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Neurology, University Hospital Muenster

Münster, North Rhine-Westphalia, 48129, Germany

Location

Related Publications (2)

  • 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.

    PMID: 15236398BACKGROUND

  • Breitenstein C, Wailke S, Bushuven S, Kamping S, Zwitserlood P, Ringelstein EB, Knecht S. D-amphetamine boosts language learning independent of its cardiovascular and motor arousing effects. Neuropsychopharmacology. 2004 Sep;29(9):1704-14. doi: 10.1038/sj.npp.1300464.

    PMID: 15114342BACKGROUND

MeSH Terms

Interventions

PramipexoleRivastigmine

Intervention Hierarchy (Ancestors)

BenzothiazolesThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPhenylcarbamatesCarbamatesAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Caterina Breitenstein, PhD

    Dept. of Neurology, University Hospital Muenster

    STUDY DIRECTOR

  • Stefan Knecht, MD

    Dept. of Neurology, University Hospital Muenster

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 3, 2005

First Posted

February 4, 2005

Study Start

January 1, 2005

Study Completion

June 1, 2006

Last Updated

June 24, 2010

Record last verified: 2006-09

Locations

DE(1)