Cognitive Rehabilitation and Galantamine for Post Stroke Cognitive Impairment

NCT01508494 | Completed Phase 2 DMC

• 2 other identifiers: C10-342010-024313-32
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cognitive Impairment; Stroke

Keywords

modification of fMRI maps after galantamine/placebo

Outcome Measures

Primary Outcomes (1)

• fMRI

  Comparison between the two groups on fMRI map activation with a N-back task at week 20

  week 20

Study Arms (2)

Galantamine

ACTIVE COMPARATOR

16mg galantamine progressively

Drug: Galantamine

placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

Galantamine DRUG

16 mg galantamine daily P/O

Galantamine

placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written consent form signed by the patient,
• Patient must be affiliated with a social security system,
• Age: 35-70,
• First symptomatic stroke,
• Brain ischemic lesion on MRI DWI consistent with a recent ischemic stroke,
• Absence of cognitive decline before the stroke,
• Detailed cognitive complaint of patient or the environment,
• Patients with a cognitive impairment (VCI-ND criteria: impairment in at least one cognitive domain with a score below 2 standard deviation according to clinical norms in at least two cognitive functions exploring this domain. VCI-ND was diagnosed in the absence of dementia according to the DSM IV,
• Absence of hospitalization for cardiovascular disease from the acute phase of the qualifying event,
• NIHSS \< 6,
• mRs \< 4,
• Absence of aphasia, apraxia and neglect severe,
• Patients not previously treated with cholinesterase inhibitors or memantine centrally acting regardless of the duration of treatment and date of prescription,
• Visual skills, auditory and oral or written expression sufficient to achieve adequate neuropsychological tests,
• Women of childbearing potential must be using contraception and a pregnancy test will be conducted at the screening visit.

You may not qualify if:

• Subjects with contraindication to MRI (a pacemaker or a defibrillator, an implanted material activated by an electrical, magnetic or mechanical carriers of hemostatic clips of intracerebral aneurysms or carotid arteries, bearing orthopedic implants, claustrophobia),
• Preexisting cognitive decline,
• VCI-ND criteria not fulfilled,
• Patients previously treated with cholinesterase inhibitors or memantine centrally acting regardless of the duration of treatment and date of prescription,
• Known allergy or intolerance to cholinesterase inhibitors or their excipients,
• Depression,
• General Health scalable,
• Progressive neurological disease causing cognitive impairment,
• Clinically significant endocrine disease,
• Patients with urinary retention or who have recently had surgery at the bladder,
• Patients with rare hereditary problems of fructose intolerance, malabsorption of glucose and galactose or sucrase-isomaltase insufficiency should not take this medicine,
• Patient with severe hepatic impairment,
• Patient with severe renal impairment,
• Patients with both hepatic and renal significant,
• Patients with sick sinus disorder or other supraventricular cardiac conduction or in those receiving concomitant drugs significantly slowing heart rate, such as digoxin and beta blockers or in patients with uncorrected electrolyte disorders,

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Service de Neurologie, CHU Toulouse Purpan

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Stroke; Cognitive Dysfunction

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2011
• First Posted: January 12, 2012
• Study Start: June 29, 2011
• Primary Completion: June 1, 2016
• Study Completion: June 22, 2016
• Last Updated: March 13, 2026

Record last verified: 2021-08

Locations

FR (1)