Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01508494 : Cognitive Rehabilitation and Galantamine for Post Stroke Cognitive Impairment
PhasePhase 2
AgesMin: 35 Years Max: 75 Years
Eligibility
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.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01508494      |      Link to official Clinicaltrials.gov listing
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