Clinical trial NCT00306124: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Alzheimer's Disease
Mild Cognitive Impairment
Healthy
Keywords: Dementia
Mild Cognitive Impairment
MCI
levodopa
learning
enhancement
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2006-03-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cognitive performance assessed by neuropsychological tests and learning paradigms under placebo and levodopa in healthy subjects and patients with dementia or Mild Cognitive Impairment.
measure: Brain activity pattern during learning under levodopa as compared to placebo in healthy subjects.
Secondary outcomes:
measure: Long-term stability of learning performance after 1 month in healthy subjects.
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: University of Muenster, Department of Neurology
state: North-Rhine Westphalia
Study officials:
affiliation: Neurology, University of Muenster, Germany
name: Stefan Knecht, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neurology, University of Muenster, Germany
name: Caterina Breitenstein, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neurology, University of Muenster, Germany
name: Julia Reinholz, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.