Effects of resveratrol on cognitive impairment due to asymptomatic carotid artery stenosis/occlusio

Phase 2

Recruiting

• Conditions: Asymptomatic carotid artery stenosis/occlusion; Carotid artery stenosis, carotid artery occlusion, dementia, vascular cognitive impairment, mild cognitive impairment

• Registration Number: JPRN-jRCTs051230013
• Lead Sponsor: Hattori Yorito

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1) Age at 20-90 years
2) Subjects with asymptomatic carotid artery moderate or severe stenosis, or occlusion
* Definition of moderate stenosis: 130 cm/s or faster of peak systokic velocity (PSV) ata stenotic lesion shown by carotid ultrasonography
*Definiation of asymptomatic status: no cerebral infarction ipsilateral to carotid artery stenosis/occlusive lesion within 6 months
3) Subjects who signed an informed consent form

Exclusion Criteria

1) Severe demented patients who fail to conduct cognitive tests.
2) Parients taking donepezil, galantamine, rivastigmine, and memantine.
3) Patients with secondary dementia (Parkinson's disease, Huntingon's disease, normal pressure hydrocephalus, pregoressive supranuclear palsy, multiple system atrophy, multiple sclerosis, head injury with sequelae, neurosyphilis, hypothyroidism, vitamin B1/B12 deficiency, folic acid deficiency)
4) Patients with more than 50% stenosis or occlusion of intracranial basilar artery, and vertebral artery
5) Patients with a past history of intrinsic psychiatric disease, or alcohol or drug dependence within 48 weeks prior to informed consent
6) Patients with severe pulmoary diseases (e.g., under home oxygen therapy)
7) Patients with a history of dose change in statins, PCSK9 inhibitors, intestinal cholesterol transporter inhibitors, and phosphodiesterase inhibitors within 4 weeks prior to informed consent
8) Patients who do not quit intake of resveratrol or nicotinamide mononucleotide by 4 weeks prior to administration of the experimental drugs
9) Patients with severe renal dysfunction (eGFR<15 mL/min/1.73m2, or hemodyalisis).
10) Patients who experienced malignancy within past five years.
11) Pregnant and breastfeeding women, or patients who do not agree with contraception.
12) Patients participating in or planning to participate in other clinical trials using other medicines ormedical devices.
13) Patients whose participation in this study is regarded as inappropriate by the principal investigator or co-investigators.

Study & Design

• Study Type: Interventional
• Study Design: Not specified