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临床试验/NCT03151460
NCT03151460已完成4 期

Dopaminergic Modulation of Declarative Memory

I.R.C.C.S. Fondazione Santa Lucia1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Performance on cognitive task

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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.

研究组 & 干预措施

Parkinson

Experimental

Patients with Parkinson's disease assuming or not Dopamine Agents

干预措施: Dopamine Agent (Drug)

结局指标

主要结局

Performance on cognitive task

时间窗: 60 min.

Performance scores on declarative memory tasks

次要结局

未报告次要终点

研究者

发起方
I.R.C.C.S. Fondazione Santa Lucia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giovanni Augusto Carlesimo

Professor

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

研究点 (1)

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