Alzheimer's DiseasePhase 4NCT00306124
Dopaminergic Enhancement of Learning and Memory in Healthy Adults and Patients With Dementia/Mild Cognitive Impairment
A Phase 4 study testing Levodopa in people with Alzheimer's Disease and Mild Cognitive Impairment, run by University Hospital Muenster at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Mild Cognitive Impairment, Healthy
- What is being tested?
- Levodopa
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2006to Mar 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- > 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Muenster, Department of Neurology
Münster, North Rhine-Westphalia, 48129
About this study
Official title: Dopaminergic Enhancement of Learning and Memory (LL_001, Project on Dementia/MCI)
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.
Read the 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.
- Conditions
- Alzheimer's Disease, Mild Cognitive Impairment, Healthy
- Being tested
- Levodopa
- Keywords
- Dementia, Mild Cognitive Impairment, MCI, levodopa, learning, enhancement
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevodopaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2006 (estimated)
- Study startJan 2006
- Study completionMar 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Investigators
- Stefan Knecht, MD, Principal investigator, Neurology, University of Muenster, GermanyCaterina Breitenstein, PhD, Principal investigator, Neurology, University of Muenster, GermanyJulia Reinholz, PhD, Study director, Neurology, University of Muenster, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306124
- Sponsor's protocol ID
- LL_001 Project on Dementia/MCI
- Status last verified
- Oct 2007
- First submitted
- 21 Mar 2006
- Last updated
- 25 Oct 2007
- Results posted
- No
Publications
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.
PubMed 15236398Breitenstein C, Knecht S. [Language acquisition and statistical learning]. Nervenarzt. 2003 Feb;74(2):133-43. doi: 10.1007/s00115-002-1466-1. German.
PubMed 12596014Floel 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.
PubMed 16087920
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dopaminergic Enhancement of Learning and Memory (LL_001, Project on Dementia/MCI)
- ClinicalTrials.gov ID
- NCT00306124
- Acronym / sponsor ID
- LL_001 Project on Dementia/MCI
- Conditions
- Alzheimer's Disease, Mild Cognitive Impairment, Healthy
- Keywords
- Dementia, Mild Cognitive Impairment, MCI, levodopa, learning, enhancement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Mar 2008 (estimated)
- First posted
- 22 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients: clinical diagnosis of AD or mild cognitive impairment
- primary language German
- Known allergy to levodopa or tetrazine
- History of medication/drug abuse
- Acute nicotine withdrawal or > 15 cigarettes per day
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levodopa | Drug | – |
Primary outcome
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.
1 secondary outcome
Long-term stability of learning performance after 1 month in healthy subjects.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2007.
- Background: PubMed 15236398Knecht 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.
- Background: PubMed 12596014Breitenstein C, Knecht S. [Language acquisition and statistical learning]. Nervenarzt. 2003 Feb;74(2):133-43. doi: 10.1007/s00115-002-1466-1. German.
- Background: PubMed 16087920Floel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Knecht, MD principal investigator
Neurology, University of Muenster, Germany
Caterina Breitenstein, PhD principal investigator
Neurology, University of Muenster, Germany
Julia Reinholz, PhD study director
Neurology, University of Muenster, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levodopa in people with Alzheimer's Disease and Mild Cognitive Impairment, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bernward Winter, MSc (+49-251-83 ext. 45695, bwinter@uni-muenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00306124, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2007.