COGICRehab

CompletedPhase 2

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

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Asset

Galantamine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Vascular cognitive impairment / dementia

Key I/E criteria

•Age 35-75•MRI contraindications excluded

Primary endpoint

•FMRI

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Eudract number2010-024313-32

Org study IDC10-34

NCT IDNCT01508494

Timeline

Milestones

Study start2011-06-29actual

Study first posted2012-01-12estimated

Primary completion2016-06actual (month precision)

Study completion2016-06-22actual

Last update posted2026-03-13actual

Assets

Drug assets

Galantamine

Study populations

Who this study enrolls

Vascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age35 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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

Exclusion criteria

•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,

•Period immediately post-myocardial infarction, recent-onset atrial fibrillation, bundle branch block second degree or higher degree, unstable angina or congestive heart failure, especially NYHA group III-IV,

•Patients with gastrointestinal obstruction or recent surgery in gastrointestinal,

•Patients receiving other cholinomimetic agents (such as ambenonium, donepezil, neostigmine, pyridostigmine, rivastigmine and pilocarpine) administered systemically,

•Breast feeding women,

•Alcohol abuse,

•Substance abuse,

•Psychiatric condition scalable,

•Patients who will have surgery during the study participation,

•Known or suspected pregnancy, confirmed by a urine pregnancy test. This test will be done prior to randomization if a woman of childbearing age without oral contraception is included in the study, if a pregnancy is declared during the participation in the study, the blind will be removed and the patient will be directed towards a specialist,

•Patient can not stop all treatment prohibited for this project at least 2 months before inclusion,

•French language level insufficient to properly participate in neuropsychological assessment,

•Transient ischemic stroke,

•Subarachnoid hemorrhage or intraparenchymal,

•Patient under protection of law or under another protection.

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Neuroimaging

1 endpoint

Primary/protocol endpoint

fMRI

Time frame:week 20

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.