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Resveratrol for vascular cognitive impairment investigating cerebralmetabolism and perfusion
(REVAMP trial)

Effects of resveratrol on cognitive impairment due to asymptomatic carotid artery stenosis/occlusion (REVAMP)

Hattori Yorito

National Cerebral and Cardiovascular Center

6-1 Kishibe-shimmachi, Suita, Osaka

yoh2019@ncvc.go.jp

Hattori Yorito

National Cerebral and Cardiovascular Center

6-1 Kishibe-shimmachi, Suita, Osaka

+81-6-6170-1070

yoh2019@ncvc.go.jp

Not Recruiting

April. 18, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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 symptomatic cerebral infarction ipsilateral to carotid artery stenosis/occlusive lesion within 6 months
3) Subjects who signed an informed consent form

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.

Both

Asymptomatic carotid artery stenosis/occlusion

Resveratrol group: A resveratrol 75 mg tablet will be orally administered twice daily.
Placebo group: A placebo tablet will be orally adm inistered twice daily.

Carotid artery stenosis, carotid artery occlusion, dementia, vascular cognitive impairment, mild cognitive impairment

resveratrol, placebo

Score change of ADAS-Cog 13 from baseline to 35 weeks

1) Change of the MoCA total score, and of the number of errors and completion time on the Trail Making Test from baseline to 35 weeks
2) Change of cerebral blood flow examined by brain 15O gas- PET from baseline to 35 weeks
3) Change of oxygen extraction fraction examinedby brain 15O gas- PET from baseline to 35 weeks
4) Change of cerebral metabolic rate of oxygen examined by brain 15O gas- PET from baseline to 35 weeks
5) Volume or grade changes of white matter hyperintensities and the number changes of lacunes examined by brain MRI from baseline to 35 weeks
6) Number changes of cerebral microbleeds examined by brain MRI from baseline to 35 weeks
7) Change of systolic and diastollic blood pressure from baseline to 35 weeks

+81-78-302-5176

Mar. 08, 2023

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