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The effects of Dengyin Naotong in patients with mild cognitive impairment in cerebral Small Vessel Disease (the De-CSVD study): a multicentre randomized controlled trial

The effects of Dengyin Naotong in patients with mild cognitive impairment in cerebral Small Vessel Disease (the De-CSVD study): a multicentre randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004786
Enrollment
Unknown
Registered
2021-04-25
Start date
2021-05-10
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mild Cognitive impairment in cerebral Small Vessel Disease (the De-CSVD study)

Interventions

Sponsors

Shandong Second Provincial General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Aged 50-70 years; 2.There is a decline in cognitive ability in memory or other cognitive areas, which lasts for at least 3 months, which is in line with the "Chinese Diagnosis and Treatment Guidelines for Cognitive Dysfunction Related to Cerebral Vascular Disease (2019)" of the Geriatric Neurology Group of the Chinese Medical Association Geriatrics Branch Diagnosis criteria for degree cognitive impairment: (1) Cognitive decline in one or more cognitive functional domains; (2) Cognitive dysfunction is insufficient to affect life independence; 3.The MOCA score was less than 26, which did not meet the diagnostic criteria of dementia in (DSM-4) 9, and the clinical dementia rating scale (CDR) score was 0.5 points; 4.There are new small subcortical infarcts, lacunae, white matter hyperintensity, enlarged perivascular space, and cerebral microhemorrhage on CT or MRI of the skull. Chinese Diagnostic and Treatment Guidelines for Cognitive Dysfunction (2019) and the Chinese Consensus on the Diagnosis and Treatment of Cerebral Small Vascular Diseases by the Chinese Medical Association Neurology Branch: (1) There are more than 2 lacunar infarcts outside the brain stem; (2) White matter hyperintensity: Fazekas score >= 2 points; (3) Cerebral micro hemorrhage: number >= 3; 5.Before the operation or examination related to the protocol, the subjects must sign the written informed consent of medication.

Exclusion criteria

Exclusion criteria: 1. Intracranial hemorrhage or heavy bleeding from other organs; 2. There was a history of new stroke within 3 months before enrollment; 3. Alcohol or drug abusers; 4. Central nervous system diseases such as Alzheimer's disease, Lewy body dementia, frontotemporal dementia, brain tumors, hydrocephalus, etc. exist. 5. Failure to complete neuropsychological tests and MRI examinations; 6. Participated in other clinical trials within 30 days before the screening visit of this study; 7. The researcher believes that it is impossible for the subject to complete the study.

Design outcomes

Primary

MeasureTime frame
Montreal Cognitive Assessment Scale (MoCA);

Secondary

MeasureTime frame
High sensitivity C-reactive protein level;Shape Connection Test (STT);Interleukin-6(IL-6);Plasma D-dimer level;Activity of Daily Living Ability Assessment Scale (ADL);Homocysteine level (Hcy);Dizziness Evaluation Scale (DHI);Geriatric Depression Scale;New vascular events;

Countries

China

Contacts

Public ContactZhang Qinghua

Shandong Second Provincial General Hospital

Zhang.qinghua@outlook.com+86 15168863112

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026