Plain English Summary
Background and study aims
Cognitive impairment is a common finding in patients with stroke, regardless of severity, with an important impact on the quality of life. Vascular cognitive impairment (VCI) describes a spectrum of cognitive disorders ranging from mild cognitive impairment (MCI) to dementia, with consequences for all cognitive domains and behaviour. This is a study to investigate the effects of N-Pep-12 treatment on the recovery of patients with post-stroke cognitive impairment. N-Pep-12 is a nutritional supplement that has been shown to have neuroprotective and pro-cognitive effects in experimental studies as well as in earlier clinical studies in patients suffering from age-related cognitive deficits.
Who can participate?
Adults aged 18 to 80 with supratentorial ischemic stroke onset 30-120 days before screening
What does the study involve?
Participants are randomly allocated to one of two groups. The first group take N-Pep-12 (90 mg) capsules, once per day, oral, for 360 days, while the second group do not receive any medication. Cognitive function is assessed after 0, 90 and 360 days.
What are the possible benefits and risks of participating?
The potential benefit of N-Pep-12 is improved cognitive function and brain recovery in patients with post-stroke cognitive impairment. The main risk for patients is developing adverse events, which are carefully assessed in order to establish a detailed safety profile of the intervention.
Where is the study run from?
RoNeuro Institute for Neurological Research and Diagnostic (Romania)
When has the study started and how long is it expected to run for?
April 2020 to October 2023
Who is funding the study?
The Society for the Study of Neuroprotection and Neuroplasticity (SSNN) (Romania)
Who is the main contact?
Stefan Strilciuc
stefan.strilciuc@ssnn.ro
Study website
Contact information
Type
Scientific
Contact name
Prof Dafin Fior Muresanu
ORCID ID
http://orcid.org/0000-0002-9536-1153
Contact details
No. 37 Mircea Eliade Street
Cluj-Napoca
400364
Romania
+40 (0)740066761
dafinm@ssnn.ro
Type
Public
Contact name
Dr Olivia Verisezan Rosu
ORCID ID
Contact details
No. 37 Mircea Eliade Street
Cluj-Napoca
400364
Romania
+40 (0)744820493
olivia.rosu@ssnn.ro
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
ClinicalTrials.gov number
Nil known
Secondary identifying numbers
FSNN20200313
Study information
Scientific title
Combined neuropsychological, neurophysiological and psychophysiological assessment of the effects of N-Pep-12 on neurorecovery in patients after ischemic stroke - N-Pep-12 Extension
Acronym
N-Pep-12 Extension
Study hypothesis
The study evaluates the therapeutic effect and the safety of a single daily dose of 90 mg of N-Pep-12 for 360 days in supporting neurorecovery in comparison to a control group of patients after ischemic stroke.
Ethics approval(s)
Approved 27/03/2020, Ethics Committee of the Iuliu Hatieganu University of Medicine and Pharmacy (8 Babeş Street, 400012 Cluj-Napoca, Romania; +40 (0)264 597 256; contact@umfcluj.ro), ref: 115/16.03.2020
Study design
Exploratory prospective randomized open-label controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Other
Study type
Treatment
Patient information sheet
No participant information sheet available
Condition
Supratentorial, radiologically confirmed ischemic stroke with the onset 30-120 days prior to screening
Intervention
Current interventions as of 02/06/2020:
The study is organised into three visits:
Visit 1 – Screening / Baseline - Study Day 0
Visit 2 – Efficacy / Safety - Study Day 90
Visit 3 – Efficacy / Safety - Study Day 360
No follow-up will be performed after the 360-day evaluation.
The study arms will be administered the following treatment courses:
1. Treatment Group: N-Pep-12 (90 mg) capsules 1/ day oral for 360 days
2. Reference Group: will not receive any kind of medication or placebo
Randomisation, Blinding and Unblinding
This is an open-label study. Communication is forbidden between assessments and the person who gives the treatment.
Patients who meet the inclusion and exclusion criteria will be randomly assigned to the treatment group or control group, in a 2:1 ratio.
Previous interventions:
The study is organised into three visits:
Visit 1 – Screening / Baseline - Study Day 0
Visit 2 – Efficacy / Safety - Study Day 90
Visit 3 – Efficacy / Safety - Study Day 360
No follow-up will be performed after the 360-day evaluation.
The study arms will be administered the following treatment courses:
1. Treatment Group: N-Pep-12 (90 mg) capsules 1/ day oral for 360 days
2. Reference Group: will not receive any kind of medication or placebo
Randomisation, Blinding and Unblinding
This is a single-blinded study. Communication is forbidden between assessments and the person who gives the treatment.
Patients meeting the inclusion and exclusion criteria will be randomly assigned to receive active treatment based on the time of their enrollment in the study. Randomisation was performed 2:1 (2 -intervention, 1 -control). The first two patients enrolled will receive active treatment, the third patient will be in the control group. This allocation scheme shall be continued until 90 patients have been enrolled.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Phase IV
Drug/device/biological/vaccine name(s)
N-Pep-12
Primary outcome measure
1. Cognitive function assessed using Montreal Cognitive Assessment (MoCA) at days 0, 90, 360
2. Emotional status assessed using Hospital Anxiety and Depression Scale at days 0, 90, 360
3. Cognitive function assessed using Digit Span (Wechsler adult intelligence scale – third edition at days 0, 90, 360
4. Cognitive function assessed using Color Trails Test at days 0, 90, 360
5. Cognitive function assessed using PSI (Processing Speed Index, Wechsler adult intelligence scale – third edition) at days 0, 90, 360
Secondary outcome measures
1. Safety variables:
1.1. Adverse events/serious adverse events measured using a questionnaire at 90 and 360 days
1.2. Mortality reported at any time during the study
2. Subgroup analysis:
2.1. Eye movements assessed using a Tobii Pro TX300 eye tracking device and analyzed using Tobii Studio software at days 0, 90, 360
2.2. Brain electrical activity assessed using electroencephalography (EEG) and analyzed quantitatively using BrainAnalyzer software at days 0, 90, 360
Overall study start date
13/03/2020
Overall study end date
31/10/2023
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Stroke onset 30-120 days prior to screening
2. Stroke is ischemic in origin, supratentorial, and radiologically confirmed (CT or MRI)
3. No significant pre-stroke disability (pre-stroke Modified Rankin Score of 0 or 1)
4. Goodglass and Kaplan Communication Scale Score of > 2 at screening
5. No other radiologically confirmed stroke in the 3 months preceding index stroke
6. Age between 18 and 80 years, inclusive
7. Signed informed consent form
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
90
Total final enrolment
107
Participant exclusion criteria
1. Pre-existing and active major neurological disease
2. Pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia (the short Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) score >3)
3. Advanced liver, kidney, cardiac, or pulmonary disease
4. A terminal medical diagnosis consistent with survival < 1 year
5. Major drug dependency, including alcohol (in the investigator’s judgment)
6. Injury of writing hand influencing cognitive or other outcome measures, in the investigator’s judgment
7. Females who are pregnant or lactating
Recruitment start date
30/04/2020
Recruitment end date
31/10/2022
Locations
Countries of recruitment
Romania
Study participating centre
RoNeuro Institute for Neurological Research and Diagnostic
37 Mircea Eliade Street
Cluj-Napoca
400364
Romania
Sponsor information
Organisation
The Foundation for the Study of Neuroscience and Neuroregeneration (Fundatia pentru Studiul Nanoneurostiintelor si Neuroregenerarii)
Sponsor details
No. 37 Mircea Eliade Street
Cluj-Napoca
400364
Romania
+40 (0)740150076
office@ssnn.ro
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Foundation for the Study of Neuroscience and Neuroregeneration (Fundatia pentru Studiul Nanoneurostiintelor si Neuroregenerarii)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal. Additional documents will be made available at a later date.
Intention to publish date
31/12/2024
Individual participant data (IPD) Intention to share
Yes
IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 3.0 | 13/03/2020 | 20/10/2023 | No | No |