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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00306124
• Other study ID #: LL_001 Project on Dementia/MCI
• Status: Recruiting
• Phase: Phase 4
• First received: March 21, 2006
• Last updated: October 24, 2007
• Start date: January 2006
• Est. completion date: March 2008

Study information

• Verified date: October 2007
• Source: University Hospital Muenster
• Contact: Bernward Winter, MSc
• Phone: +49-251-83
• Email: bwinter[@]uni-muenster.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cognition Disorders
• Healthy
• Mild Cognitive Impairment

Intervention

Drug:
• Levodopa

Locations

Country	Name	City	State
Germany	University of Muenster, Department of Neurology	Muenster	North-Rhine Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Breitenstein C, Knecht S. [Language acquisition and statistical learning]. Nervenarzt. 2003 Feb;74(2):133-43. Review. German. — View 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. — View Citation

Knecht S, Breitenstein C, Bushuven S, Wailke S, Kamping S, Flöel A, Zwitserlood P, Ringelstein EB. Levodopa: faster and better word learning in normal humans. Ann Neurol. 2004 Jul;56(1):20-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive performance assessed by neuropsychological tests and learning paradigms under placebo and levodopa in healthy subjects and patients with dementia or Mild Cognitive Impairment.
Primary	Brain activity pattern during learning under levodopa as compared to placebo in healthy subjects.
Secondary	Long-term stability of learning performance after 1 month in healthy subjects.

External Links

•   Dept. of Neurology, University of Muenster