Condition category
Circulatory System
Date applied
15/04/2020
Date assigned
29/04/2020
Last edited
02/06/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 May 2024

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

Trial website

Contact information

Type

Scientific

Primary contact

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

Additional contact

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 number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

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

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

Trial setting

Other

Trial 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

Phase

Phase IV

Drug names

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 trial start date

13/03/2020

Overall trial end date

31/05/2024

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

Patient

Age group

Adult

Gender

Both

Target number of participants

90

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

31/05/2023

Locations

Countries of recruitment

Romania

Trial 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.

IPD sharing statement
The data-sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2024

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/06/2020: The interventions have been updated. 16/04/2020: Trial's existence confirmed by Ethics Committee of the Iuliu Hatieganu University of Medicine and Pharmacy.