NCT00306124

Brief Summary

This study aims to determine whether levodopa is effective in boosting learning and memory in healthy subjects and patients with dementia or Mild Cognitive Impairment. We also examine in healthy subjects using functional magnetic resonance imaging which brain regions mediate improved learning after levodopa administration.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 22, 2006

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

October 25, 2007

Status Verified

October 1, 2007

First QC Date

March 21, 2006

Last Update Submit

October 24, 2007

Conditions

Alzheimer's DiseaseMild Cognitive ImpairmentHealthy

Keywords

DementiaMild Cognitive ImpairmentMCIlevodopalearningenhancement

Outcome Measures

Primary Outcomes (2)

  • Cognitive performance assessed by neuropsychological tests and learning paradigms under placebo and levodopa in healthy subjects and patients with dementia or Mild Cognitive Impairment.

  • Brain activity pattern during learning under levodopa as compared to placebo in healthy subjects.

Secondary Outcomes (1)

  • Long-term stability of learning performance after 1 month in healthy subjects.

Interventions

LevodopaDRUG

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients: clinical diagnosis of AD or mild cognitive impairment
  • primary language German

You may not qualify if:

  • Known allergy to levodopa or tetrazine
  • History of medication/drug abuse
  • Acute nicotine withdrawal or \> 15 cigarettes per day
  • \> 6 cups/glasses of coffee, caffeine drinks or energy drinks per day
  • \> 50 grams of alcohol per day
  • Severe hypertonia (systole \>160 mm Hg)
  • Severe arteriosclerosis
  • Diabetes, asthma, or glaucoma
  • Severe hearing disability
  • no focal brain lesions
  • Premorbid depression or psychosis
  • Medication with dopamine agonists or antagonists
  • Parkinsonian symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Muenster, Department of Neurology

Münster, North Rhine-Westphalia, 48129, Germany

RECRUITING

Related Publications (3)

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

    PMID: 12596014BACKGROUND

  • Floel A, Hummel F, Breitenstein C, Knecht S, Cohen LG. Dopaminergic effects on encoding of a motor memory in chronic stroke. Neurology. 2005 Aug 9;65(3):472-4. doi: 10.1212/01.wnl.0000172340.56307.5e.

    PMID: 16087920BACKGROUND

MeSH Terms

Conditions

Alzheimer DiseaseCognitive DysfunctionDementia

Interventions

Levodopa

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Intervention Hierarchy (Ancestors)

DihydroxyphenylalanineCatecholaminesAminesOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsTyrosine

Study Officials

  • Stefan Knecht, MD

    Neurology, University of Muenster, Germany

    PRINCIPAL INVESTIGATOR

  • Caterina Breitenstein, PhD

    Neurology, University of Muenster, Germany

    PRINCIPAL INVESTIGATOR

  • Julia Reinholz, PhD

    Neurology, University of Muenster, Germany

    STUDY DIRECTOR

Central Study Contacts

Bernward Winter, MSc

CONTACT

+49-251-83bwinter@uni-muenster.de

Study Design

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

Study Record Dates

First Submitted

March 21, 2006

First Posted

March 22, 2006

Study Start

January 1, 2006

Study Completion

March 1, 2008

Last Updated

October 25, 2007

Record last verified: 2007-10

Locations

DE(1)