NCT01508494

Cognitive Rehabilitation and Galantamine for Post Stroke Cognitive Impairment

Evaluation de l'efficacité de la Galantamine Versus Placebo associée à Une Revalidation Neuropsychologique Chez Des Patients présentant un Trouble Cognitif après un Premier Infarctus cérébral : étude en Neuroimagerie Fonctionnelle

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France · Other Government
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The investigators would like to conduct a double blind placebo-controlled prospective study to show the impact of a treatment combining a specific cognitive rehabilitation program and acetylcholinesterase inhibitors on executive function of young patients 3 months after a first symptomatic stroke. The secondary objectives will be to assess cognitive changes performance (executive but also non trained functions such as memory) before and after treatments and treatment effect on activity of daily living and on quality of life. The main objective of this study is to show the impact of this combined treatment on brain activation maps in VCI-ND patients in the post-acute phase (3 months) after a stroke. Treatment effect will be assessed by functional MRI (fMRI) while patients will be performing a specific executive task. The investigators hypothesize that the specific rehabilitation associated with acetylcholinestrase inhibitors treatment will focalize cerebral activation observed in fMRI, improve executive functions specifically, improve non trained cognitive functions (generalization effect).

Detailed description

Recent studies, including the investigators', have shown that neuropsychological alteration is frequent and underestimated after stroke (Vascular Cognitive Impairment (VCI). VCI-No Dementia (VCI-ND) is characterized by a mild cognitive alteration in relation to a cerebrovascular lesion, diagnosed by a neuropsychological assessment, and without major alteration in the activities of daily living, but that can represent an issue in return to work for young patients. Some studies demonstrated that cognitive rehabilitation or pharmacological intervention may to improve patients' cognition and social functioning. The investigators hypothesize that a combination of pharmacological and cognitive rehabilitation treatments is beneficial on executive but also other cognitive function in VCI-ND patients Therefore the investigators would like to conduct a double blind placebo-controlled prospective study to show the impact of a treatment combining a specific cognitive rehabilitation program and acetylcholinesterase inhibitors on executive function of young patients 3 months after a first symptomatic stroke. The secondary objectives will be to assess cognitive changes performance (executive but also non trained functions such as memory) before and after treatments and treatment effect on activity of daily living and on quality of life. The main objective of this study is to show the impact of this combined treatment on brain activation maps in VCI-ND patients in the post-acute phase (3 months) after a stroke. Treatment effect will be assessed by functional MRI (fMRI) while patients will be performing a specific executive task. The investigators hypothesize that the specific rehabilitation associated with acetylcholinestrase inhibitors treatment will focalize cerebral activation observed in fMRI, improve executive functions specifically, improve non trained cognitive functions (generalization effect).

Conditions

• Stroke
• Cognitive Impairment

Interventions

Type	Name	Description
DRUG	Galantamine	16 mg galantamine daily P/O
DRUG	placebo	placebo

Timeline

• Start date: 2011-06-29
• Primary completion: 2016-06-01
• Completion: 2016-06-22
• First posted: 2012-01-12
• Last updated: 2026-03-13

Locations

1 site across 1 country: France