StrokePhase 2COGICRehabNCT01508494
Cognitive Rehabilitation and Galantamine for Post Stroke Cognitive Impairment
A Phase 2 study testing Galantamine in people with Stroke and Cognitive Impairment, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Stroke, Cognitive Impairment
- What is being tested?
- Galantamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jun 2011to 22 Jun 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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).
Read the 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
- Being tested
- Galantamine, placebo
- Keywords
- modification of fMRI maps after galantamine/placebo
- Medical subject headings
- Stroke, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GalantamineDrug
16 mg galantamine daily P/O
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Galantamine | Active comparator | 16mg galantamine progressively Receives: Drug: Galantamine |
| placebo | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI
Comparison between the two groups on fMRI map activation with a N-back task at week 20
Measured: week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study start29 Jun 2011
- Primary completionJun 2016
- Study completion22 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508494
- Sponsor's protocol ID
- C10-34
- Other IDs
- 2010-024313-32
- Acronym
- COGICRehab
- Status last verified
- Aug 2021
- First submitted
- 1 Jul 2011
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Planton M, Nemmi F, Pages B, Albucher JF, Raposo N, Danet L, Peran P, Pariente J. Galantamine combined with cognitive rehabilitation on post-stroke cognitive impairment: a proof-of-concept study. Brain Inj. 2025 Jan 28;39(2):108-117. doi: 10.1080/02699052.2024.2409355. Epub 2024 Oct 3.
PubMed 39359162
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01508494
- Acronym / sponsor ID
- COGICRehab / C10-34
- Conditions
- Stroke, Cognitive Impairment
- Keywords
- modification of fMRI maps after galantamine/placebo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 29 Jun 2011 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- 22 Jun 2016 (actual)
- First posted
- 12 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Galantamine | Active comparator | Drug: Galantamine16mg galantamine progressively |
| placebo | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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,
Key exclusion criteria (29 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Galantamine16 mg galantamine daily P/O | Drug | Galantamine |
| placeboplacebo | Drug | placebo |
Primary outcome
fMRI
Time frame: week 20
Comparison between the two groups on fMRI map activation with a N-back task at week 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Results publication: PubMed 39359162Planton M, Nemmi F, Pages B, Albucher JF, Raposo N, Danet L, Peran P, Pariente J. Galantamine combined with cognitive rehabilitation on post-stroke cognitive impairment: a proof-of-concept study. Brain Inj. 2025 Jan 28;39(2):108-117. doi: 10.1080/02699052.2024.2409355. Epub 2024 Oct 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Galantamine in people with Stroke and Cognitive Impairment, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI (time frame: week 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01508494, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.