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Dopaminergic Modulation of Declarative Memory

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ClinicalTrials.gov Identifier: NCT03151460
Recruitment Status : Completed
First Posted : May 12, 2017
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
Giovanni Augusto Carlesimo, I.R.C.C.S. Fondazione Santa Lucia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Dopamine Agent Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: All PD patients were examined in two conditions: following the standard dopamineric medication ("on") and following a 12-18 hours of treatment wash-out ("off"). Normal controls were examined twice with no drug assumption.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dopaminergic Modulation of Declarative Memory
Actual Study Start Date : September 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Parkinson
Patients with Parkinson's disease assuming or not Dopamine Agents
Drug: Dopamine Agent
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 Name: Dopaminergic drugs

No Intervention: Normal Controls
Age and education comparable healthy subjects



Primary Outcome Measures :
  1. Performance on cognitive task [ Time Frame: 60 min. ]
    Performance scores on declarative memory tasks



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151460


Locations
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Italy
Fondazione S. Lucia
Rome, Italy, 00179
Sponsors and Collaborators
I.R.C.C.S. Fondazione Santa Lucia
Investigators
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Principal Investigator: Giovanni Carlesimo, MD Fondazione S. Lucia

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Responsible Party: Giovanni Augusto Carlesimo, Professor, I.R.C.C.S. Fondazione Santa Lucia
ClinicalTrials.gov Identifier: NCT03151460     History of Changes
Other Study ID Numbers: 1
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dopamine
Dopamine Agents
Dopamine Agonists
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents