Dopaminergic Modulation of Declarative Memory

NCT03151460 | Completed Phase 4

• 1 other identifier: 1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Performance on cognitive task

  Performance scores on declarative memory tasks

  60 min.

Study Arms (2)

Parkinson

EXPERIMENTAL

Patients with Parkinson's disease assuming or not Dopamine Agents

Drug: Dopamine Agent

Normal Controls

NO INTERVENTION

Age and education comparable healthy subjects

Interventions

Dopamine Agent DRUG

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.

Also known as: Dopaminergic drugs

Parkinson

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of idiopathic Parkinson Disease made by a neurologist according to the London Brain Bank criteria.

You may not qualify if:

• 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.

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead

Study Sites (1)

Fondazione S. Lucia

Rome, 00179, Italy

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Dopamine Agents

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Officials

• Giovanni Carlesimo, MD

  Fondazione S. Lucia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 12, 2017
• Study Start: September 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 12, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)