- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03151460
Dopaminergic Modulation of Declarative Memory
May 11, 2017 updated by: Giovanni Augusto Carlesimo, I.R.C.C.S. Fondazione Santa Lucia
The study investigates the effect of dopaminergic stimulation over declarative memory functions in Parkinson's disease (PD) patients.
At this aim, 20 PD patients will receive declarative memory tasks in two different conditions: after 12-18 hours of dopaminergic stimulation withdrawal ("off" condition) and after the first daily dose dopaminergic therapy ("on" condition).
20 healthy controls will also administered the two tasks in two conditions with the same inter-session delay as PD patients, but without taking drugs.
Study Overview
Detailed Description
Parkinson's disease (PD) is frequently accompanied by declarative memory deficits.
It has been hypothesized that these latter could be related to dopaminergic depletion within the fronto-striatal network.
However, the nature of this relationship is not clearly understood.
In this study we aim to assess the role of daily dopaminergic stimulation on the retrieval processes needed to perform different cognitive tasks.
A group of PD patients will be administered declarative memory task both "on" (standard medication intake) and "off" (12/18 hours after the last medication intake).
A group of comparable normal controls will also present with the same cognitive task twice, without any drug assumption.
Understanding the effect of dopamine treatment on declarative memory processes will allow standard medication treatment to be adjusted in order to take into account both motor and cognitive features of Parkinson's disease.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Rome, Italy, 00179
- Fondazione S. Lucia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of idiopathic Parkinson Disease made by a neurologist according to the London Brain Bank criteria.
Exclusion Criteria:
- disease duration ≥ 5 years; diagnosis of dementia based on clinical criteria and confirmed by a Mini-Mental State Examination score < 26; presence of other neurological and/or psychiatric illnesses in the patient's clinical history.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Parkinson
Patients with Parkinson's disease assuming or not Dopamine Agents
|
Patients were assessed in two experimental conditions that were performed on different days, with an intersession interval of about one month.
In the "off" condition PD subjects performed the experimental tasks in the morning after 12/18 hours of Dopamine Agent withdrawal.
In the "on" condition they were examined 90-120 minutes after they had taken their first morning dose of levodopa and/or dopamine agonists.
Other Names:
|
NO_INTERVENTION: Normal Controls
Age and education comparable healthy subjects
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performance on cognitive task
Time Frame: 60 min.
|
Performance scores on declarative memory tasks
|
60 min.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Giovanni Carlesimo, MD, Fondazione S. Lucia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 1, 2014
Primary Completion (ACTUAL)
April 1, 2016
Study Completion (ACTUAL)
April 1, 2016
Study Registration Dates
First Submitted
May 9, 2017
First Submitted That Met QC Criteria
May 11, 2017
First Posted (ACTUAL)
May 12, 2017
Study Record Updates
Last Update Posted (ACTUAL)
May 12, 2017
Last Update Submitted That Met QC Criteria
May 11, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Cardiotonic Agents
- Sympathomimetics
- Dopamine
- Dopamine Agents
Other Study ID Numbers
- 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinson's Disease
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
Assistance Publique - Hôpitaux de ParisFrance Parkinson AssociationUnknownHealthy Controls | Parkinson's Disease With LRRK2 Mutation | Parkinson's Disease Without LRRK2 MutationFrance
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
Universidade Federal de PernambucoCompletedParkinson's Disease.Brazil
-
University Hospital, GrenobleCompletedParkinson's Disease (Disorder)France
-
Neurocrine BiosciencesVoyager TherapeuticsCompletedBrain Diseases | Central Nervous System Diseases | Nervous System Diseases | Parkinson's Disease | Parkinsonian Disorders | Movement Disorders | Neurodegenerative Diseases | Idiopathic Parkinson's Disease | Basal Ganglia DiseaseUnited States
-
Second Affiliated Hospital of Soochow UniversityShanghai Regenelead Therapies Co., Ltd.RecruitingAdvanced Parkinson's DiseaseChina
-
AbbVieRecruitingParkinson's Disease (PD)Germany, Denmark, Spain
-
Beijing Tiantan HospitalRecruitingPD - Parkinson's DiseaseChina
-
Hubert FernandezRecruitingParkinson's Disease, IdiopathicUnited States
Clinical Trials on Dopamine Agent
-
Universitaire Ziekenhuizen KU LeuvenUnknownAppetite RegulationBelgium
-
Seoul National University Bundang HospitalCompletedChronic Renal Insufficiency | Coronary AngiographyKorea, Republic of
-
Medical College of WisconsinRecruiting
-
Hacettepe UniversityNot yet recruitingDental Caries on Pit and Fissure Surface
-
MiNK TherapeuticsCompletedRespiratory Distress Syndrome, AdultUnited States
-
Lundquist Institute for Biomedical Innovation at...General ElectricCompletedContrast Enhancement on Cardiac CTUnited States
-
Erasmus Medical CenterNot yet recruitingSolid Tumor, AdultNetherlands
-
IRCCS Policlinico S. DonatoCompletedAbdominal Aortic AneurismItaly
-
National Research Centre, EgyptCompletedTooth HypersensitivityEgypt
-
Multiple Myeloma Research ConsortiumNot yet recruitingRefractory Multiple Myeloma | Relapse Multiple Myeloma