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Alzheimer DiseasePhase 2NCT05269173

Efficacy and Safety of Flos Gossypii Flavonoids Tablet in the Treatment of Alzheimer's Disease

A Phase 2 study testing Flos gossypii flavonoids tablet in people with Alzheimer Disease, run by Capital Medical University at 19 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In clinical trials of preclinical pharmacodynamic studies, Flos Gossypii Flavonoids Tablet has been proved to significantly improve the learning and memory ability of Alzheimer's disease model. Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Alzheimer Disease
What is being tested?
Flos gossypii flavonoids tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
19 sitesChina
Study dates
29 Oct 2020to 5 Nov 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 50 to 85 years old (including 50 and 85 years old), male or female;
  • Meet the diagnostic criteria of "likely ad dementia" of the National Institute on aging Alzheimer's disease association (NIA-AA) (2011);
  • The subjects are primary school graduates / graduates and above, and have the ability to complete the cognitive ability test and other tests specified in the program;
  • Memory loss lasted for at least 6 months and tended to worsen gradually;
  • Subjects with mild or moderate illness: 11 ≤ MMSE ≤ 26;
  • Total score of Clinical Dementia Rating Scale (CDR):
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  • Mild dementia: CDR = 1.0; Moderate dementia: CDR = 2.0;
  • The total score of Hachinski scale(HIS) ≤ 4;
  • The total score of Hamilton Depression Scale (HAMD 17 item version) is ≤ 10;
  • There was no obvious positive sign in nervous system examination;
  • Coronal scanning of head MRI in screening stage: the MTA grade of medial temporal lobe atrophy visual assessment scale is grade 2 or higher, and the signal changes of T2 FLAIR sequence in coronal position of hippocampus. If the subject can provide the head MRI film that meets the requirements within 1 month before screening, it can be used as the basis for enrollment without repeated shooting; If the researcher cannot judge whether the subject's condition has changed, the coronal MRI scan of the head before enrollment can be added;
  • The subjects should have stable and reliable caregivers, who will take care of them at least 3 days a week and at least 2 hours a day. The caregivers will accompany the subjects to participate in the whole process of the study. Caregivers must accompany the subjects to the study visit and assist the investigator in completing the Neuropsychiatric Inventory (NPI), Alzheimer's Disease Collaborative Study-Ability of Daily Living Scale (ADCS-ADL), and Clinician Interview Based Impression of Severity (CIBIC -plus), and other scale scores;
  • Agree to participate and sign the informed consent form by the legal guardian. Due to the subject's limited cognitive ability and other reasons, the subject's signature is allowed to be left blank, and the reason is explained. In addition, the legal guardian shall sign the reason statement, and the legal guardian shall sign the informed consent;
  • Meet the criteria the traditional Chinese medicine of AD which is characterized by the syndrome of insufficient sea of marrow/cerebral collateral stasis. According to the Dementia Syndrome Classification Scale (SDSD), one of the syndromes of insufficient sea of marrow/cerebral collateral stasis can be met.

Who cannot join

  • During screening, MRI examination showed significant focal lesions, fulfilling one of the following conditions:
  • ① There were more than 2 infarcts with diameter > 2 cm at any site;
  • ② MRI examination showed that there were infarcts with arbitrary diameter in key parts (such as thalamus, hippocampus, entorhinal cortex, paraolfactory cortex, angular gyrus, cortex and other subcortical gray matter nuclei);
  • ③ Fazekas scale grade of white matter lesions > 2;
  • ④ There are other imaging evidences that do not support mild and moderate AD;
  • Dementia caused by other reasons: vascular dementia, central nervous system infection, Creutzfeldt Jakob disease, Huntington's disease, Parkinson's disease, Lewy body dementia, traumatic dementia, other physical and chemical factors (such as drug poisoning, alcoholism, carbon monoxide poisoning, etc.), important physical diseases (such as hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial space occupying lesions (such as subdural hematoma, brain tumor), endocrine disorders (such as thyroid disease, parathyroid disease), and vitamin B12, folic acid deficiency or any other known cause;
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  • Have suffered from central nervous system diseases (including stroke, optic neuromyelitis, epilepsy, etc.);
  • Subjects who were diagnosed with psychiatric disorders according to DSM-V criteria, including schizophrenia or other mental diseases, bipolar disorder, severe depression or delirium;
  • Abnormal laboratory indexes: liver function (ALT and AST) exceeded 1.5×ULN, renal function (CR) exceeded 1.5×ULN, and creatine kinase exceeded 2×ULN;
  • Untreated hypertensive and hypotensive subjects at screening, or hypertensive subjects with uncontrolled hypertension after treatment; subjects with good blood pressure control after treatment can be determined by the investigator to be suitable for inclusion in this study;
  • Within 1 month of the screening visit, the subject has new or ongoing unstable or serious heart, lung, liver, kidney and hematopoietic diseases according to the judgment of the researcher, and does not meet the conditions for clinical research;
  • Clinically, people with significant allergic reaction history, especially drug allergy history, or known allergy to this product and its excipients;
  • Dyspepsia, esophageal reflux, gastric bleeding or peptic ulcer disease, frequent heartburn (≥ once a week) or any surgical operation that may affect drug absorption (such as partial / total gastrectomy, partial / total small bowel resection and cholecystectomy) within 6 months before screening;
  • Alcohol or drug abusers;
  • Human immunodeficiency virus antibody (ant HIV) and Treponema pallidum antibody (ant TP) are positive;
  • Those who are currently using and cannot stop using drugs for Alzheimer's disease;
  • Screening for cholinesterase inhibitors, N-methyl-D-aspartate receptor antagonists (NMDA antagonists), mental retardants, antiparkinsonian drugs and opioid analgesics taken within 1 month before the visit;
  • There are uncorrectable visual and auditory disorders, and the neuropsychological test and scale evaluation cannot be completed;
  • Female subjects with positive pregnancy test or lactation and subjects unable to take effective contraceptive measures or have family planning;
  • Participated in other clinical trials within 3 months before the screening visit;
  • There are other situations that the researcher believes are not suitable to participate in this study.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

China19 sites

  • Xuanwu Hospital of Capital Medical University

    Beijing, Beijing Municipality, 100053

  • Oriental Hospital of Beijing University of traditional Chinese Medicine

    Beijing, Beijing Municipality, 100078

  • Affiliated Hospital of Chengde Medical College

    Chengde, Hebei, 067020

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400042

  • Daqing People's Hospital

    Daqing, Heilongjiang, 163711

  • Sun Yat Sen Memorial Hospital of Sun Yat sen University

    Guangzhou, Guangdong, 510289

  • Hefei Second People's Hospital

    Hefei, Anhui, 230012

  • Lu'an Hospital of traditional Chinese Medicine

    Lu'an, Anhui, 237005

  • Luoyang First Hospital of traditional Chinese Medicine

    Luoyang, Henan, 471099

  • Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan, 646000

  • Jiangsu Hospital of traditional Chinese Medicine

    Nanyang, Jiangsu, 210004

  • PLA Northern Theater Air Force Hospital

    Shenyang, Liaoning, 110092

  • The First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

  • Taizhou Hospital of traditional Chinese Medicine

    Taizhou, Jiangsu, 225399

  • Wuxi Second People's Hospital

    Wuxi, Jiangsu, 214001

  • Shanxi Hospital of traditional Chinese Medicine

    Xi’an, Shanxi, 710003

  • Xi'an High Tech Hospital

    Xi’an, Shanxi, 710077

  • Xidian Group Hospital

    Xi’an, Shanxi, 710077

  • Yangzhou First People's Hospital

    Yangzhou, Jiangsu, 225007

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of Flos Gossypii Flavonoids Tablet in the Treatment of Mild and Moderate Alzheimer's Disease

In clinical trials of preclinical pharmacodynamic studies, Flos Gossypii Flavonoids Tablet has been proved to significantly improve the learning and memory ability of Alzheimer's disease model. Phase I clinical tolerance test is to observe the human body's tolerance to Flos Gossypii Flavonoids Tablet, and provide a basis for the formulation of safe and reasonable dosing regimens for phase II clinical trials. Therefore, a Phase II clinical trial is now being conducted to explore the efficacy and safety of the Flos Gossypii Flavonoids Tablet in the treatment of mild to moderate Alzheimer's disease (marinus sea deficiency/brain collateral stasis syndrome). In this study, the researchers will use a multicenter, randomized, double-blind, placebo-controlled parallel method to recruit AD patients to confirm the efficacy and safety of Flos Gossypii Flavonoids Tablet. Confirmation of drug efficacy will be observed through changes in AD patients' general cognitive and different cognitive domain functions, daily living activities, and symptom severities.

Read the detailed description

Cotton flower is a Xinjiang Uygur ethnic medicine, and its main active ingredients are flavonoids. Studies have proved that flavonoids have strong characteristics of antioxidant stress and anti-inflammatory response. Preclinical pharmacodynamic studies on rats showed that the Flos Gossypii Flavonoids Tablet could significantly improve the learning and memory ability of AD model caused by different factors, and the mechanism may be related to its inhibition of oxidative stress and inflammatory response. A total of 57 subjects were enrolled in the Phase I tolerance clinical study. The results showed that the experimental drug may temporarily increase the three indexes of glutamic oxaloacetic transaminase, creatine kinase and lactate dehydrogenase, which can self-recovery in a short time. Combined with the safety evaluation results of phase I clinical trial, Flos Gossypii Flavonoids Tablet is a drug with high safety.

Being tested
Flos gossypii flavonoids tablet
Keywords
medullary sea deficiency, brain collateral stasis syndrome
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flos gossypii flavonoids tabletDrug

    The distribution ratio between the groups was 1:1:1, and the stratification factor was the degree of illness CDR score. In the study, the entry of each subject into the high-dose group, low-dose group or placebo group will be determined by the randomized system.

Study groups in NCT05269173
Study groupRoleWhat they receive
Active group(low dose group)Active comparatorTake 5 tablets each time (including 3 tablets of study drug and 2 tablets of placebo), 3 times a day, a total of 2.7g per day. Take it with warm water half an hour before meals.
Receives: Drug: Flos gossypii flavonoids tablet
Active group(high dose group)Active comparatorTake 5 tablets of the study drug each time, 3 times a day, a total of 4.5g per day. Take it with warm water half an hour before meals.
Receives: Drug: Flos gossypii flavonoids tablet
Control groupPlacebo comparatorTake 5 tablets of the control drug (placebo) each time, 3 times a day, 4.5g a day. Take it with warm water half an hour before meals.
Receives: Drug: Flos gossypii flavonoids tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Alzheimer's Disease Assessment Scale-Cognitive section(ADAS-cog/11)

    Differences between the low-dose and high-dose groups in changes in ADAS cog/11 scores (relative to baseline) at weeks 13 and 26 were compared with the placebo group.

    The ADAS-cog/11 measures 11 items: word recall, commands, constructional praxis, naming objects or fingers, ideational praxis, orientation, word recognition, remembering word recognition test instructions, spoken language ability, word-finding difficulty and comprehension. The total score ranges from 0 to 70, with lower scores representing milder disease.

    Measured: Change from baseline in ADAS-cog scores at Week 26

Secondary outcomes (6)

  1. Mini-mental State Examination (MMSE)

    Differences between the low-dose and high-dose groups in changes in MMSE scores (relative to baseline) at weeks 13 and 26 were compared with the placebo group.

    The MMSE scale can reflect the mental state and the degree of cognitive impairment of the subjects, with a total score of 30 points. The higher the score, the better the subject's condition.

    Measured: Change from baseline in MMSE scores at Week 26

  2. Alzheimer's Disease Co-operative Study Activities of Daily Living (ADCS-ADL)

    Differences between the low-dose and high-dose groups in changes in ADCS-ADL scores (relative to baseline) at weeks 13 and 26 were compared with the placebo group.

    The ADCS-ADL scale can reflect the degree of impairment of the subjects' daily life ability, with a total score of 78 points. The higher the score, the better the subjects' living ability.

    Measured: Change from baseline in ADCS-ADL scores at Week 26

  3. Clinician Interview Based Impression of Severity (CIBIC-plus)

    Differences between the low-dose and high-dose groups in changes in CIBIC-plus scores (relative to baseline) at weeks 13 and 26 were compared with the placebo group.

    The CIBIC-plus scale is based on interviews with patients and their caregivers by research physicians to ask, record and assess changes in patients' conditions. Outcomes assessed were: Caregiver Meeting-Clinical Impression Change, Subject Meeting-Clinical Impression Change, and Overall Clinical Impression Change.

    Measured: Change from baseline in CIBIC-plus scores at Week 26

  4. Neuropsychiatric Inventory (NPI)

    Differences in changes in 12-item behavioral domain scores (relative to baseline) on the NPI scale at weeks 13 and 26 between the low-dose and high-dose groups compared with placebo.

    The NPI scale is an interview conducted by the research doctor based on the patient's caregiver to ask the patient's mental and emotional changes. The questions included 12 items including delusions, hallucinations, depression, and anxiety, each of which identified the severity, frequency, and psychological stress of the caregiver.

    Measured: Change from baseline the scores of 12 behavioral domains in NPI at Week 26.

  5. Neuropsychiatric Inventory (NPI)

    Differences in changes in caregiver stress scores (relative to baseline) on the NPI scale at weeks 13 and 26 between the low-dose and high-dose groups compared with placebo.

    Measured: Change from baseline in Caregiver Stress Score on the NPI Scale at Week 26

  6. Dementia syndrome classification scale (SDSD)

    Differences between the low-dose and high-dose groups in changes in SDSD scores (relative to baseline) at week 26 were compared with the placebo group.

    This project selects the type of medullary sea insufficiency and the type of brain collateral stasis from the SDSD scale for evaluation. The maximum score for the assessment is 30 points. If the total score is less than 7 points, the syndrome is not established, and if the total score is ≥ 7 points, the syndrome is established.

    Measured: Change from baseline in SDSD scores at Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2022
  2. Study start29 Oct 2020
  3. Primary completion13 Aug 2024
  4. Study completion5 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05269173
Sponsor's protocol ID
HJG- MHHZHTP-XJWWEYY
Status last verified
Nov 2024
First submitted
25 Feb 2022
Last updated
12 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Flos gossypii flavonoids tablet in people with Alzheimer Disease, run by Capital Medical University at 19 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alzheimer's Disease Assessment Scale-Cognitive section(ADAS-cog/11) (time frame: Change from baseline in ADAS-cog scores at Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05269173.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.

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