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Dopaminergic Modulation of Declarative Memory

Dopaminergic Modulation of Declarative Memory

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03151460
Enrollment
40
Registered
2017-05-12
Start date
2014-09-30
Completion date
2016-04-30
Last updated
2017-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

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.

Interventions

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.

Sponsors

I.R.C.C.S. Fondazione Santa Lucia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Performance on cognitive task60 min.Performance scores on declarative memory tasks

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026