Dopaminergic Modulation of Declarative Memory

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dopaminergic Modulation of Declarative Memory

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: Dopamine Agent


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parkinson<br>Patients with Parkinson's disease assuming or not Dopamine Agents | Drug: Dopamine Agent<br>* 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.<br>* Other names: Dopaminergic drugs;|
| No Intervention: Normal Controls<br>Age and education comparable healthy subjects | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance on cognitive task | Performance scores on declarative memory tasks | 60 min. |