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Dopaminergic Enhancement of Learning and Memory in Healthy Adults and Patients With Dementia/Mild Cognitive Impairment

NCT ID: NCT00306124

Last Updated: 2007-10-25

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-03-31

Brief Summary

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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.

Detailed Description

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Prior work of our group shows that the dopamine precursor levodopa markedly improves word learning success in healthy subjects. In this randomized, placebo-controlled, double-blind trial, we probe whether administration of levodopa improves learning performance as compared to placebo administration on neuropsychological tests and in an associative learning paradigm. We postulate that levodopa improves learning success and memory performance in healthy subjects, while the effect in patients with dementia or Mild Cognitive Impairment might depend on other factors, including severity of memory impairment.

Conditions

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Alzheimer's Disease Mild Cognitive Impairment Healthy

Keywords

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Dementia Mild Cognitive Impairment MCI levodopa learning enhancement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Levodopa

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Muenster

OTHER

Sponsor Role lead

Principal Investigators

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Stefan Knecht, MD

Role: PRINCIPAL_INVESTIGATOR

Neurology, University of Muenster, Germany

Caterina Breitenstein, PhD

Role: PRINCIPAL_INVESTIGATOR

Neurology, University of Muenster, Germany

Julia Reinholz, PhD

Role: STUDY_DIRECTOR

Neurology, University of Muenster, Germany

Locations

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University of Muenster, Department of Neurology

Münster, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Bernward Winter, MSc

Role: CONTACT

Phone: +49-251-83

Email: [email protected]

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)

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.

Reference Type BACKGROUND
PMID: 16087920 (View on PubMed)

Other Identifiers

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LL_001 Project on Dementia/MCI

Identifier Type: -

Identifier Source: org_study_id