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Dopaminergic Modulation of Declarative Memory

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Dopamine Agent
Sponsored by
I.R.C.C.S. Fondazione Santa Lucia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Fondazione S. Lucia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Parkinson

Normal Controls

Arm Description

Patients with Parkinson's disease assuming or not Dopamine Agents

Age and education comparable healthy subjects

Outcomes

Primary Outcome Measures

Performance on cognitive task
Performance scores on declarative memory tasks

Secondary Outcome Measures

Full Information

First Posted
May 9, 2017
Last Updated
May 11, 2017
Sponsor
I.R.C.C.S. Fondazione Santa Lucia
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1. Study Identification

Unique Protocol Identification Number
NCT03151460
Brief Title
Dopaminergic Modulation of Declarative Memory
Official Title
Dopaminergic Modulation of Declarative Memory
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
I.R.C.C.S. Fondazione Santa Lucia

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parkinson
Arm Type
Experimental
Arm Description
Patients with Parkinson's disease assuming or not Dopamine Agents
Arm Title
Normal Controls
Arm Type
No Intervention
Arm Description
Age and education comparable healthy subjects
Intervention Type
Drug
Intervention Name(s)
Dopamine Agent
Other Intervention Name(s)
Dopaminergic drugs
Intervention Description
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.
Primary Outcome Measure Information:
Title
Performance on cognitive task
Description
Performance scores on declarative memory tasks
Time Frame
60 min.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Carlesimo, MD
Organizational Affiliation
Fondazione S. Lucia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione S. Lucia
City
Rome
ZIP/Postal Code
00179
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Dopaminergic Modulation of Declarative Memory

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