Efficacy and Safety of Yangxue Qingnao Pills in the Treatment of Mild to Moderate Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT04780399|
Recruitment Status : Not yet recruiting
First Posted : March 3, 2021
Last Update Posted : April 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease Yangxue Qingnao Pills Randomized||Drug: Yangxue Qingnao pills Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||216 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy and Safety of Yangxue Qingnao Pills in the Treatment of Mild to Moderate Alzheimer's Disease:a Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clicnial Trial|
|Estimated Study Start Date :||May 1, 2021|
|Estimated Primary Completion Date :||March 1, 2024|
|Estimated Study Completion Date :||December 30, 2024|
Experimental: Yangxue Qingnao pills high dose group
Yangxue Qingnao pills 7.5 g per time,2 times per day.
Drug: Yangxue Qingnao pills
72 subjects in the Yangxue Qingnao pills group take 7.5g of Yangxue Qingnao pills each time, twice a day, 0.5 hours after breakfast and dinner, taking with warm water.
Experimental: Yangxue Qingnao pills lower dose group
Yangxue Qingnao pills 5 g per time,2 times per day, and placebo identified to Yangxue Qingnao pills 2.5 g per time, 2 times per day.
Drug: Yangxue Qingnao pills
72 subjects in the Yangxue Qingnao pills group take 5g of Yangxue Qingnao pills and 2.5g placebo identified to Yangxue Qingnao pills each time, twice a day, 0.5 hours after breakfast and dinner, taking with warm water.
Placebo Comparator: Placebo group
Placebo identified to Yangxue Qingnao pills 7.5 g per time,2 times per day
72 subjects in the placebo group take 7.5g placebo identified to Yangxue Qingnao pills each time, twice a day, 0.5 hours after breakfast and dinner, taking with warm water.
- Alzheimer's Disease Assessment Scale- Cognition Subscale (ADAS-cog) [ Time Frame: Change from baseline ADAS-cog score at Week 48 ]The Alzheimer's Disease Assessment Scale-Cognitive Subscale test is one of the most frequently used tests to measure cognition in research studies and clinical trials for new drugs and other interventions.The ADAS-Cog consists of 11 parts and takes approximately 30 minutes to administer.The test administrator adds up points for the errors in each task of the ADAS-Cog for a total score ranging from 0 to 70. The greater the dysfunction, the greater the score. A score of 70 represents the most severe impairment and 0 represents the least impairment.
- Clinical dementia rating scale-sum box(CDR-SB) [ Time Frame: Change from baseline CDR-SB score at Week 48 ]The Clinical Dementia Rating Scale (CDR) is a global assessment instrument that yields global and Sum of Boxes (CDR-SB) scores, with the global score regularly used in clinical and research settings to stage dementia severity. The CDR-SB score is obtained by summing each of the domain box scores, with scores ranging from 0 to 18. Higher score means severe global cognition impairment.
- Mini-Mental State Examination(MMSE) [ Time Frame: Change from baseline MMSE score at Week 48 ]TThe Mini-Mental Status Examination offers a quick and simple way to quantify cognitive function and screen for cognitive loss. It tests the individual's orientation, attention, calculation, recall, language and motor skills. It takes ~ 5-10 minutes to administer The range for the total MMSE score is 0 to 30, higher score means better cognition.
- Neuropsychiatric Inventory(NPI) [ Time Frame: Change from baseline NPI score at Week 48 ]The NPI is a semistructured clinician interview of caretakers in which the severity and frequency of disturbance in 12 symptom domains is rated
- Alzheimer's Disease Cooperative Study-Activities of Daily Living scale (ADCS-ADL/23) [ Time Frame: Change from baseline ADCS-ADL/23 score at Week 48 ]The Alzheimer's Disease Cooperative Study (ADCS) tested 23-item version (ADCS-ADL/23) includes more complex ADL for the assessment of mild to moderate AD, such as reading books or magazines, pastime activities, or household chores. Ratings take about 20 minutes and are based on information obtained from the patient and caregiver. The scores range from 0 to 78, higher scores indicating less functional impairment.
- Blood biomarkers including Aβ42, Aβ40, T-tau, P-tau181, NfL, TOM1, IL-1R1,IL-1b, IL-6, IL-8, TNF-a, FB, FH, sCR1, MCP-1, eotaxin-1, Ach, ChEI [ Time Frame: Change from baseline of Aβ42, Aβ40, T-tau, P-tau181, NfL, TOM1, IL-1R1,IL-1b, IL-6, IL-8, TNF-a, FB, FH, sCR1, MCP-1, eotaxin-1, Ach, ChEI at Week 48 ]
- Hippocampus volume with MRI [ Time Frame: Change of hippocampus volume with MRI after 48 weeks'treatment from baseline ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780399
|Contact: Jinzhou Tian, MD.PhDemail@example.com|
|Contact: Jing Shi, MDfirstname.lastname@example.org|