Single Arm Clinical Trial of Small Molecule Natural Flavonoid Compounds for Intervention in Neurodegenerative Diseases

1. Explore the effects of natural plant flavonoids on the positive intervention mechanism of neurotransmitter transmission physiological indicators changes (EEG) in the brain of the study subjects;
2. Investigate the effects of natural plant flavonoids in positively intervening clinical symptoms of the study subjects.

Study Overview

• Status: Not yet recruiting
• Conditions: Neurodegenerative Diseases
• Intervention / Treatment: Drug: SMARTO ONE

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Li Liu; Phone Number: 16619733315; Email: lily0496@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age: 25-70 years
2. Patients complaining of sleep disorders, mood disorders (unstable mood, irritability, depression and anxiety) and cognitive decline (people with memory, decreased reaction time, BPSD symptoms) within one month
3. Montreal Cognitive Assessment Scale (MOCA) score ≤26; if MOCA score is not satisfied, then Pittsburgh Sleep Quality Index (PSQI) score >10 and Hamilton Anxiety Scale (HAMA) score >14 or Hamilton Depression Scale (HAMD) score ≥8 are required
4. Patients who can understand and communicate in language, and complete aphasia patients are not included;
5. Patients who agree to participate in this clinical observation and sign the informed consent form.

Exclusion Criteria:

1. Patients with severe organ diseases such as heart, kidney, and liver failure, chronic lung diseases such as COPD, and severe diabetes;
2. Patients with severe uncontrolled hypertension;
3. Patients who have taken antipsychotic drugs within the past two weeks;
4. Patients with the core features of Lewy body dementia or significant behavioral variant frontotemporal dementia;
5. Patients with various malignant tumors;
6. Patients with progressive stroke, transient ischemic attack, cerebral hemorrhage after cerebral infarction, and cerebral arteritis;
7. Patients with brain tumors, brain trauma, cerebral parasitic diseases, and other conditions;
8. Pregnant or lactating women;
9. Patients allergic to the known ingredients used in this trial;
10. Patients with active ulcers or bleeding tendencies;
11. Patients with neurodegenerative diseases such as Huntington's disease, amyotrophic lateral sclerosis, and Pick's disease;
12. Other patients who are deemed unsuitable to participate in this trial by the investigators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: SMARTO ONE

Drug: SMARTO ONE; The SMARTO ONE® small molecule natural flavonoid compound product is provided by Beijing Jiafurui Biological Technology Co., Ltd. The intervention agent formula consists of extracts from Polygonum cuspidatum leaves, Fructus ligustri lucidi, Prunus mume, Semen ziziphi spinosae, celery, resistant maltodextrin, and steviol glycoside. Each package of the test product (3g) contains a total flavonoid content of 150mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montreal Cognitive Assessment (MoCA)	This outcome measure assesses cognitive ability and memory, with evaluation based on a scoring system.The total score ranges from 0 to 30 points, with scores lower than 26 indicating the presence of cognitive impairment. The lower the score, the more severe the disease.	4 weeks
Pittsburgh Sleep Quality Index (PSQI)	The evaluation criteria for this outcome measure are as follows: 0-5 points indicate very good sleep quality; 6-10 points indicate average sleep quality; 11-15 points indicate poor sleep quality; 16-21 points indicate very poor sleep quality.	4 weeks
Hamilton Anxiety Rating Scale (HAMA)	The evaluation criteria for this outcome measure are as follows: 0-6 points indicate no anxiety symptoms; 7-14 points indicate possible anxiety; 15-21 points indicate definite anxiety; 22-29 points indicate significant anxiety; and scores exceeding 29 points suggest severe anxiety.	4 weeks
Hamilton Depression Scale(HAMD)	The evaluation criteria for this outcome measure are as follows:a score of less than 8 is normal, a score of 8-20 may indicate depression, a score of 21-35 may indicate depression, and a score of more than 35 may not indicate severe depression	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerry of participating with adverse events	This is a safety outcome.	baseline, 4 weeks
Adverse event occurrence rate	This is a safety outcome.	baseline, 4 weeks
Abnormality rate of routine blood tests	This is a safety outcome. Included in the outcome indicators are red blood cell count (WBC), haemoglobin concentration (Hb), white blood cell count (WBC), neutrophil count (Neut), lymphocyte count (Lymph), monocyte count (Mono), eosinophil count (Eos), basophil count (Baso) and platelet count (PLT). The abnormal blood count rate was obtained by dividing the number of people with abnormal blood counts by the total number of people with abnormal blood counts.	baseline, 4 weeks
Liver function-Alanine aminotransferase#ALT#	This is a safety outcome.	baseline, 4 weeks
Liver function-Aspartate aminotransferase (AST)	This is a safety outcome.	baseline, 4 weeks
Liver function-Total Protein(TP)	This is a safety outcome.	baseline, 4 weeks
Electrocardiogram	This is a safety outcome.This outcome measure primarily observes ST segment changes to evaluate the presence or improvement of myocardial ischemia.	baseline, 4 weeks
Body temperature	This is a safety outcome.	baseline, 4 weeks
Heart rate	This is a safety outcome.	baseline, 4 weeks
Number of breaths in 1 min	This is a safety outcome.	baseline, 4 weeks
Blood pressure-Diastolic blood pressure(mmHg)	This is a safety outcome.	baseline, 4 weeks
Blood pressure-Systolic blood pressure(mmHg)	This is a safety outcome.	baseline, 4 weeks

Collaborators and Investigators

• Sponsor: Mei Han

Study record dates

Study Major Dates

• Study Start (Estimated): August 15, 2023
• Primary Completion (Estimated): June 15, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 17, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurodegenerative Diseases
• Other Study ID Numbers: SMARTO ONE-202305-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No