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COMPLETEDPHASE2

Efficacy and Safety of TMBCZG in Mild to Moderate Vascular Dementia

Efficacy and Safety of Twice Daily TMBCZG in Mild to Moderate Vascular Dementia: Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Trial

NCT03230071•Dongzhimen Hospital, Beijing

View on ClinicalTrials.gov

Summary

The study will be a 24-week multicentre, double-blind, placebo-controlled phase Ⅱa trial with 4 treatment arms in China. Participants aged 55-80 years will be randomized to TMBCZG-high dose(84mg per day), TMBCZG- medium dose(56mg per day), TMBCZG- low dose(28mg per day) or to placebo. The primary endpoint will be VADAS-Cog and CDR-SB. Secondary outcomes included changes in MMSE and ADL. Patients' safety will be assessed by recording of adverse events, clinical examinations, electrocardiography and laboratory tests. The patients, caregivers, and investigators will be blinded to the treatment allocations.

Eligibility

Age

55 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients meeting the clinical diagnosis of probable vascular dementia(VaD) established according to the National Institute of Neurological Disorders and Stroke and the Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS-AIREN)were eligible to participate:
•1. Dementia defined by clinical core criteria,
•2. Cerebrovascular disease, defined by history of stroke, as well as multiple basal ganglia and white matter lacunes, or extensive periventricular white matter lesions( excluded medial temporal lobe atrophy or other special image),
•3. A relationship between dementia and Cerebrovascular disease, manifested or inferred by the presence of one or more of the following: (a) onset of dementia within 3 months following a recognized stroke; (b) abrupt deterioration in cognitive functions; or fluctuating, stepwise progression of cognitive deficits.
•Mild to Moderate Dementia with MMSE score of ≤26 and ≥11;
•Aged ≥55 and ≤80 years old in both gender;
•Weighing of ≥45kg and ≤90kg;
•Adequate vision and hearing ability to complete all study tests;
•With a stable caregiver.
•Have a certain level of language competence (can read simple articles and write simple sentences);
+1 more criteria

Exclusion Criteria

•A medical history of other dementia types, like mixed dementia, Alzheimer's disease, frontotemporal dementia, Parkinson's disease dementia, dementia with Lewy bodies, Huntington disease, et al;
•Subdural hematoma, traffic hydrocephalus, brain tumor, thyroid disease,vitamin deficiency or other diseases which can lead to cognitive impediment;
•Major depression (HAMD≥17) or major anxious(HAMA≥12);
•Subject can't complete related test due to severe neurologic deficits, such as hemiplegia, aphasia, audio-visual disorder and so forth;
•Severe cardiovascular disease(severe arrhythmia, myocardial infarction within 3 months, New York Heart Association Functional Classification III-IV, systolic pressure≥180mmHg or ≤90mmHg);
•Severe liver or kidney dysfunction (alanine aminotransferase or aspartate transaminase is more than 1.5 times the upper limit of normal, or serum creatinine is more than the upper limit of normal);
•Uncontrolled diabetes(glycosylated hemoglobin is more than 2 times the upper limit of normal);
•Asthma, chronic obstructive pulmonary disease, multiple neuritis, myasthenia gravis and muscle atrophy;
•Severe indigestion, gastrointestinal obstruction, gastric and duodenal ulcers and other gastrointestinal disorders that can affect drug absorption;
•A medical history of epileptic history, glaucoma, alcoholism, or psycho-substance abuse;
+5 more criteria

Locations (1)

Dongzhimen Hospital ,Beijing University of Chinese Medicine

Beijing, Beijing Municipality, China

Key Dates

Start Date

July 28, 2017

Primary Completion Date

August 22, 2019

Completion Date

February 5, 2021

Last Updated

March 2, 2021

Enrollment

160

ACTUAL participants

Conditions

Vascular Dementia

Interventions

TMBCZG

DRUG

placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of TMBCZG in Mild to Moderate Vascular Dementia

Inclusion Criteria

Exclusion Criteria

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