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

Primary Purpose

Alzheimer's Disease, Mild Cognitive Impairment, Healthy

Status

Unknown status

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Levodopa

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Dementia, Mild Cognitive Impairment, MCI, levodopa, learning, enhancement

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria for patients with dementia: Patients: clinical diagnosis of AD or mild cognitive impairment primary language German Exclusion Criteria for healthy subjects and patients with dementia/MCI: 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

Sites / Locations

University of Muenster, Department of NeurologyRecruiting

Outcomes

Primary Outcome Measures

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 Outcome Measures

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

Full Information

NCT ID

NCT00306124

First Posted

March 21, 2006

Last Updated

October 24, 2007

Sponsor

University Hospital Muenster

1. Study Identification

Unique Protocol Identification Number

NCT00306124

Brief Title

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

Official Title

Dopaminergic Enhancement of Learning and Memory (LL_001, Project on Dementia/MCI)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2007

Overall Recruitment Status

Unknown status

Study Start Date

January 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital Muenster

4. Oversight

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease, Mild Cognitive Impairment, Healthy

Keywords

Dementia, Mild Cognitive Impairment, MCI, levodopa, learning, enhancement

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Levodopa

Primary Outcome Measure Information:

Title

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

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bernward Winter, MSc

Phone

+49-251-83

Ext

45695

bwinter@uni-muenster.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stefan Knecht, MD

Organizational Affiliation

Neurology, University of Muenster, Germany

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Caterina Breitenstein, PhD

Organizational Affiliation

Neurology, University of Muenster, Germany

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Julia Reinholz, PhD

Organizational Affiliation

Neurology, University of Muenster, Germany

Official's Role

Study Director

Facility Information:

Facility Name

University of Muenster, Department of Neurology

City

Muenster

State/Province

North-Rhine Westphalia

ZIP/Postal Code

48129

Country

Germany

Individual Site Status

Recruiting

12. IPD Sharing Statement

Citations:

PubMed Identifier

15236398

Citation

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.

Results Reference

background

PubMed Identifier

12596014

Citation

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

Results Reference

background

PubMed Identifier

16087920

Citation

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.

Results Reference

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

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