Cognitive Rehabilitation and Galantamine for Post Stroke Cognitive Impairment
Condition: Stroke; Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

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).
    

Intervention name(s): Galantamine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 16 mg galantamine daily P/O; placebo
Intervention MeSH terms: Galantamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: modification of fMRI maps after galantamine/placebo