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Effect of Astragalus Membranaceus on the Improvement of Cognitive Function in Alzheimer's Disease

Primary Purpose

Alzheimer's Disease

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Astragalus
Routine treatment
Sponsored by
Fujian Medical University Union Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:Participants with a clinical diagnosis of cognitive impairment and orthostatic hypotension. Adults signed informed consents.

-

Exclusion Criteria:Patients who have one of the following were excluded from this trial:

  1. secondary hypotension.
  2. definite hypersensitivity or contraindication to the study medications.
  3. being treated or history of serious diseases such as stroke or transient ischemic attack, claustrophobia, bipolar disorder, schizophrenia, seizures, drug or alcohol abuse, malignancy, renal failure and dialysis treatment, liver disease (hepatitis), renal disease.
  4. unable to have magnetic resonance imaging (MRI) or electroencephalogram (EEG).
  5. use of health foods, supplements, and medicines that may affect cognitive function, 6) have severe visual and/or hearing impairment.

7) self-reported use of non-pharmacological or pharmacological therapies to treat hypotension.

8) during pregnancy or lactation 9) participation in other clinical studies within the past 3 months.

-

Sites / Locations

  • Fujian Medical University Union HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Astragalus membranaceus

Routine treatment

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline MoCA scores at 3 months
The Montreal Cognitive Assessment (MoCA)

Secondary Outcome Measures

Change from baseline HRV (ms) at 3months
Heart rate variability (HRV) was calculated as the maximum bpm - minimum bpm
The plasma concentration of Cycloastragenol (μg/ml)
Change from the baseline plasma α-synuclein levels (ng/ml) at 3 months
Change from baseline Vic at 3 months
The intra-cellular compartment (Vic) of the Neurite Orientation Dispersion and Density Imaging (NODDI) model represents diffusion within the axons and cells.
Change from baseline ODI at 3 months
NODDI models the dispersion of axonal fibers with the use of an Orientation Dispersion Index (ODI)
Change from baseline PAF (Hz) at 3 months
The alpha-peak frequency (PAF) is the frequency with the highest power within the alpha-band.
Change from baseline mean arterial pressure after 3 minutes of upright posture versus decubitus position (mmHg) at 3 months.
Mean arterial pressure was calculated as ⅓ pulse pressure + diastolic pressure.

Full Information

First Posted
October 11, 2022
Last Updated
July 2, 2023
Sponsor
Fujian Medical University Union Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05578443
Brief Title
Effect of Astragalus Membranaceus on the Improvement of Cognitive Function in Alzheimer's Disease
Official Title
Effect of Astragalus Membranaceus on the Improvement of Cognitive Function in Alzheimer's Disease: a Randomized Controlled Trial Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
July 30, 2025 (Anticipated)
Study Completion Date
July 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Medical University Union Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Alzheimer's disease (AD), the most common cause of dementia, is characterized by cognitive impairment, mental and behavioural abnormalities, and social dysfunction. Current treatments can only delay the progression of AD, not cure it completely. In vitro studies have shown that Astragalus has toxic effects such as anti-hypoxia injury of nerve cells, anti-free radical damage, anti-excitatory amino acids, etc. It can be used to expand cerebral vessels, increase cerebral blood flow, improve cerebral microcirculation, protect brain cells, and repair damaged brain cells. However, the clinical effects of add-on Astragalus in improving cognition in these patients remain unclear. Therefore, this pragmatic clinical trial aims to determine the efficacy and safety of add-on Astragalus in improving cognition in patients with AD

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Astragalus membranaceus
Arm Type
Experimental
Arm Title
Routine treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Astragalus
Intervention Description
Astragalus tablets 20g, warm water to drink, once a day, take for 1 year, during which routine treatment should also be carried out.
Intervention Type
Behavioral
Intervention Name(s)
Routine treatment
Intervention Description
Limit water and sodium intake. Raise the head of the bed. Standardized amount of exercise. Low temperature diet and small meals. Avoid alcohol, coffee and dehydration. The treatment lasted for 3 months.
Primary Outcome Measure Information:
Title
Change from baseline MoCA scores at 3 months
Description
The Montreal Cognitive Assessment (MoCA)
Time Frame
Baseline vs 3 months after treatment.
Secondary Outcome Measure Information:
Title
Change from baseline HRV (ms) at 3months
Description
Heart rate variability (HRV) was calculated as the maximum bpm - minimum bpm
Time Frame
Baseline vs 3 months after treatment.]
Title
The plasma concentration of Cycloastragenol (μg/ml)
Time Frame
Time Frame: 1 hour after treatment.
Title
Change from the baseline plasma α-synuclein levels (ng/ml) at 3 months
Time Frame
Baseline vs 3 months after treatment.
Title
Change from baseline Vic at 3 months
Description
The intra-cellular compartment (Vic) of the Neurite Orientation Dispersion and Density Imaging (NODDI) model represents diffusion within the axons and cells.
Time Frame
Baseline vs 3 months after treatment
Title
Change from baseline ODI at 3 months
Description
NODDI models the dispersion of axonal fibers with the use of an Orientation Dispersion Index (ODI)
Time Frame
Baseline vs 3 months after treatment
Title
Change from baseline PAF (Hz) at 3 months
Description
The alpha-peak frequency (PAF) is the frequency with the highest power within the alpha-band.
Time Frame
Baseline vs 3 months after treatment
Title
Change from baseline mean arterial pressure after 3 minutes of upright posture versus decubitus position (mmHg) at 3 months.
Description
Mean arterial pressure was calculated as ⅓ pulse pressure + diastolic pressure.
Time Frame
Baseline vs 3 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:Participants with a clinical diagnosis of Alzheimer's disease. - Exclusion Criteria:Patients who have one of the following were excluded from this trial: being treated or history of serious diseases such as stroke or transient ischemic attack, claustrophobia, bipolar disorder, schizophrenia, seizures, drug or alcohol abuse, malignancy, renal failure and dialysis treatment, liver disease (hepatitis), renal disease. unable to have magnetic resonance imaging (MRI) or electroencephalogram (EEG). use of health foods, supplements, and medicines that may affect cognitive function, have severe visual and/or hearing impairment. during pregnancy or lactation participation in other clinical studies within the past 3 months. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaodong Pan
Phone
86218341
Email
pxd77316@163.com
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaodong Pan
Phone
86218341
Email
xieheyb@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Astragalus Membranaceus on the Improvement of Cognitive Function in Alzheimer's Disease

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