Efficacy, Safety of Astragalus Membranaceus in Mild-to-Moderate Alzheimer's Disease (NCT06694597) | Clinical Trial Compass
CompletedPhase 2
Efficacy, Safety of Astragalus Membranaceus in Mild-to-Moderate Alzheimer's Disease
China76 participantsStarted 2023-05-01
Plain-language 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
Who can participate
Age range50 Years – 85 Years
SexALL
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Inclusion criteria
✓. Participate voluntarily and sign an informed consent form
✓. Age 50-85 years old;
✓. Memory loss for at least 6 months with a tendency of progressive deterioration;
✓. Mild or moderate patients, i.e. MMSE total score:14\< MMSE total score\<24, 0.5≤CDR-GS≤2;
✓. The highest likelihood of AD (medial temporal lobe atrophy visual rating scale grade 2 or higher on coronal imaging) as demonstrated by cranial MRI scanning and oblique coronal hippocampal scanning review at the time of screening;
✓. Hachinski Ischemia Scale (HIS) score \< 4;
✓. A diagnosis of dementia according to the DSM-V and a diagnosis of "probable AD" according to the NIA-AA criteria;
✓. No significant positive signs on neurological examination;
Exclusion criteria
✕. Non-AD-induced memory and cognitive impairment, such as a diagnosis of other types of dementia, including, but not limited to, Mixed Disease Dementia, Vascular Dementia, Parkinson's Disease Dementia, Lewy Body Dementia, Huntington's Chorea-related Dementia, Normal Pressure Hydrocephalus, Brain Tumour, Progressive Supranuclear Palsy, Frontotemporal Lobar Dementia, etc.; Endocrine system pathology (e.g., Thyroid Disease, Parathyroid Disease) as well as Folic Acid, Vitamin B12 deficiency or any other causes of dementia; the presence of impaired consciousness, etc;
What they're measuring
1
The primary efficacy outcome measure will be the absolute change in the Clinical Dementia Rating
Timeframe: Participants were followed up for 24 weeks after baseline.
✕. A history of seizures; psychosis, including but not limited to schizophrenia, schizoaffective disorder, bipolar disorder, or delirium; and
✕. Hamilton Depression Scale (HAMD) score \>17;
✕. Significant focal lesions on MRI with one of the following: a. \>2 infarct foci \>2cm in diameter; b. Infarct foci in key areas such as thalamus, hippocampus, internal olfactory cortex, parafrontal olfactory cortex, angular gyrus, cortex, and other subcortical grey matter nuclei; and c. Cerebral white matter damage with a Fazekas Scale score ≥3;
✕. Patients who have taken other herbal preparations within the past 1 month;
✕. Astragalus allergy or contraindication;
✕. Presence of abnormal laboratory parameters: impaired renal function (blood Cr \> 1.5xULN) or creatinine clearance (C cr) \< 50mL/min or abnormal liver function (ALT or AST \> 2xULN);
✕. Patients who refused or had contraindications to MRI or EEG (pacemakers, coronary and peripheral arterial stents, metallic implants, claustrophobia, or severe visual or hearing impairments); refused to have blood drawn;