Alzheimer'sPhase 2/3NCT03090516
Clinical Efficacy of Ginkgo Biloba Extract in the Treatment of Alzheimer's Disease
A Phase 2/3 study testing Ginkgo biloba dispersible tablets, Donepezil and Ginkgo biloba dispersible tablets and Donepezil in people with Alzheimer's, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This project explores Ginkgo biloba ester dispersible tablets influence on cognitive function in patients with mild-to-moderate elderly, to observe the effects of different intervention time on cognitive function, for alzheimer's patients in drug rehabilitation treatment provides an effective solution. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer's
- What is being tested?
- Ginkgo biloba dispersible tablets, Donepezil and Ginkgo biloba dispersible tablets and Donepezil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2016to 10 Mar 2020
- Phase
- Phase 2/3
- 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
- All patients were diagnosed with dementia caused by AD in 2011, the latest diagnostic criteria for Alzheimer's disease (NIA-AA), according to the patient's clinical and cranial imaging findings
- Improved Hachinski ischemic scale score <4
- All patients underwent head CT and / or MRI examinations and laboratory tests to rule out other causes of dementia
- MMSE(High school≤24,Primary school≤20;illiteracy≤17)
- CDR 1-2
- The subjects and nurses signed informed consent, and the nursing staff were able to take responsibility for the supervision of the participants
Show all 9Show fewer
- The subjects were stable
- Cooperate, willing to complete all parts of the research, and have the ability to complete the study alone or with the help of the nursing staff
- To cooperate with the study, do not live alone, such as living alone should keep in touch with the nurse every day.
Who cannot join
- Heart lung kidney disease, may interfere to evaluate the efficacy and safety of patients at risk or special disease,for example:Congestive heart failure et al.
- According to NINDS-AIREN standard (Roman GC et al 1993) is currently diagnosed as possible vascular dementia
- Improved Hachinski ischemic scale score（MHIS）≥4
- Diagnosis of severe depression, schizophrenia, and other major neurodegenerative disorders, according to the DSM-IV axis
- Neurological or other medical disorders that affect the function of the central nervous system,like Moderate anemia,Vitamin B12 or folic acid deficiency, et al. Not with the cognitive function examination (including blindness, deafness, severe language disorders).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ting Wu
Nanjing, Jiangsu, 210000
Ting Wu, professor, 18851122018, wuting80000@126.com
Wanrong Zhang, master, 15851875395, zwr10010533@163.com
About this study
Official title: Clinical Study on Improving the Cognitive Function of Patients With Mild to Moderate Alzheimer's Disease by Using Ginkgo Biloba Dispersible Tablets
This project explores Ginkgo biloba ester dispersible tablets influence on cognitive function in patients with mild-to-moderate elderly, to observe the effects of different intervention time on cognitive function, for alzheimer's patients in drug rehabilitation treatment provides an effective solution.
Read the detailed description
The assessment of cognitive scales included Minimum Mental State Examination(MMSE), Alzheimer's Disease Assessment Scale-cognition(ADAS-cog), Neuropsychiatric inventory(NPI), quality of Life of Life in Alzheimer's disease(Qol-ADL), activities of Daily living(ADL), Geriatric Depression scale(GDS).Biochemical test included cholesterol, triglycerides, and low density lipoprotein.
- Conditions
- Alzheimer's
- Being tested
- Ginkgo biloba dispersible tablets, Donepezil, Ginkgo biloba dispersible tablets and Donepezil
- Keywords
- Ginkgo biloba dispersible tablets, Alzheimer's
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginkgo biloba dispersible tabletsDrug
Also called Ginkgo biloba dispersible tablets and Donepezil;Donepezil
Arm C：Ginkgo biloba dispersible tablets，0.15g at a time， three times a day.
DonepezilDrug
Also called Ginkgo biloba dispersible tablets;Ginkgo biloba dispersible tablets and Donepezil
Arm A：Aricept 5mg/day
Ginkgo biloba dispersible tablets and DonepezilDrug
Also called Donepezil;Ginkgo biloba dispersible tablets
Arm B：Ginkgo biloba dispersible tablets，0.15g at a time， three times a day.Aricept 5mg/day.
| Study group | Role | What they receive |
|---|---|---|
| Arm A ：Donepezil | Experimental | A：People are randomly divided into three groups according to the educational conditiono，gender and age. Receives: Drug: Donepezil |
| Arm B ：Donepezil and Ginkgo biloba dispersible tablets | Experimental | B：People are randomly divided into three groups according to the educational conditiono，gender and age. Receives: Drug: Ginkgo biloba dispersible tablets and Donepezil |
| Arm C：Ginkgo biloba dispersible tablets | Experimental | C：People are randomly divided into three groups according to the educational conditiono，gender and age. Receives: Drug: Ginkgo biloba dispersible tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scales to assess
MMSE（Mini-mental State Examinatlon）
Measured: change from baseline MMSE at 12weeks
Electroencephalography P300
participants distinguish two voice and count them at the same time.we record their electroencephalography
Measured: change from baseline at 12weeks
liver function (blood)
liver function（aspartate transaminase，Alanine aminotransferase，low density lipoprotein，Serum total cholesterol，Triglyceride）
Measured: change from baseline at 12weeks
1.5T MRI changes
Magnetic Resonance Imaging
Measured: changes before and after 12weeks
Alzheimer disease assessment scale (ADAS-cog)
ADAS-cog
Measured: change from baseline ADAS-cog at 12 weeks
activities of daily living scale (ADL)
ADL
Measured: change from baseline ADL at 12 weeks
Change in neuropsychiatrc interventory (NPI)
NPI
Measured: change from baseline NPI at 12weeks
Change in geriatric depression scale (GDS)
GDS
Measured: change from baseline GDS at 12 weeks
renal function
blood urea nitrogen
Measured: change from baseline at 12weeks
Secondary outcomes (1)
ECG
Electrocardiograph
Measured: change from baseline at 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start10 Aug 2016
- Primary completion10 Mar 2020 (estimated)
- Study completion10 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer'sStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting Wu, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Ting Wu, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090516
- Sponsor's protocol ID
- Ginkgo biloba
- Status last verified
- Aug 2019
- First submitted
- 4 Mar 2017
- Last updated
- 7 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Improving the Cognitive Function of Patients With Mild to Moderate Alzheimer's Disease by Using Ginkgo Biloba Dispersible Tablets
- ClinicalTrials.gov ID
- NCT03090516
- Acronym / sponsor ID
- Ginkgo biloba
- Conditions
- Alzheimer's
- Keywords
- Ginkgo biloba dispersible tablets, Alzheimer's
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 10 Aug 2016 (actual)
- Primary completion
- 10 Mar 2020 (estimated)
- Study completion
- 10 Mar 2020 (estimated)
- First posted
- 24 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project explores Ginkgo biloba ester dispersible tablets influence on cognitive function in patients with mild-to-moderate elderly, to observe the effects of different intervention time on cognitive function, for alzheimer's patients in drug rehabilitation treatment provides an effective solution.
Detailed description
The assessment of cognitive scales included Minimum Mental State Examination(MMSE), Alzheimer's Disease Assessment Scale-cognition(ADAS-cog), Neuropsychiatric inventory(NPI), quality of Life of Life in Alzheimer's disease(Qol-ADL), activities of Daily living(ADL), Geriatric Depression scale(GDS).Biochemical test included cholesterol, triglycerides, and low density lipoprotein.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A ：Donepezil | Experimental | Drug: DonepezilA：People are randomly divided into three groups according to the educational conditiono，gender and age. |
| Arm B ：Donepezil and Ginkgo biloba dispersible tablets | Experimental | Drug: Ginkgo biloba dispersible tablets and DonepezilB：People are randomly divided into three groups according to the educational conditiono，gender and age. |
| Arm C：Ginkgo biloba dispersible tablets | Experimental | Drug: Ginkgo biloba dispersible tabletsC：People are randomly divided into three groups according to the educational conditiono，gender and age. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- All patients were diagnosed with dementia caused by AD in 2011, the latest diagnostic criteria for Alzheimer's disease (NIA-AA), according to the patient's clinical and cranial imaging findings
- Improved Hachinski ischemic scale score <4
- All patients underwent head CT and / or MRI examinations and laboratory tests to rule out other causes of dementia
- MMSE(High school≤24,Primary school≤20;illiteracy≤17)
- CDR 1-2
Key exclusion criteria (5 listed)
- Heart lung kidney disease, may interfere to evaluate the efficacy and safety of patients at risk or special disease,for example:Congestive heart failure et al.
- According to NINDS-AIREN standard (Roman GC et al 1993) is currently diagnosed as possible vascular dementia
- Improved Hachinski ischemic scale score（MHIS）≥4
- Diagnosis of severe depression, schizophrenia, and other major neurodegenerative disorders, according to the DSM-IV axis
- Neurological or other medical disorders that affect the function of the central nervous system,like Moderate anemia,Vitamin B12 or folic acid deficiency, et al. Not with the cognitive function examination (including blindness, deafness, severe language disorders).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ginkgo biloba dispersible tabletsAlso: Ginkgo biloba dispersible tablets and Donepezil;DonepezilArm C：Ginkgo biloba dispersible tablets，0.15g at a time， three times a day. | Drug | Arm C：Ginkgo biloba dispersible tablets |
| DonepezilAlso: Ginkgo biloba dispersible tablets;Ginkgo biloba dispersible tablets and DonepezilArm A：Aricept 5mg/day | Drug | Arm A ：Donepezil |
| Ginkgo biloba dispersible tablets and DonepezilAlso: Donepezil;Ginkgo biloba dispersible tabletsArm B：Ginkgo biloba dispersible tablets，0.15g at a time， three times a day.Aricept 5mg/day. | Drug | Arm B ：Donepezil and Ginkgo biloba dispersible tablets |
Primary outcome
Scales to assess
Time frame: change from baseline MMSE at 12weeks
MMSE（Mini-mental State Examinatlon）
Electroencephalography P300
Time frame: change from baseline at 12weeks
participants distinguish two voice and count them at the same time.we record their electroencephalography
liver function (blood)
Time frame: change from baseline at 12weeks
liver function（aspartate transaminase，Alanine aminotransferase，low density lipoprotein，Serum total cholesterol，Triglyceride）
1.5T MRI changes
Time frame: changes before and after 12weeks
Magnetic Resonance Imaging
Alzheimer disease assessment scale (ADAS-cog)
Time frame: change from baseline ADAS-cog at 12 weeks
ADAS-cog
activities of daily living scale (ADL)
Time frame: change from baseline ADL at 12 weeks
ADL
Change in neuropsychiatrc interventory (NPI)
Time frame: change from baseline NPI at 12weeks
NPI
Change in geriatric depression scale (GDS)
Time frame: change from baseline GDS at 12 weeks
GDS
renal function
Time frame: change from baseline at 12weeks
blood urea nitrogen
1 secondary outcome
ECG
Time frame: change from baseline at 12weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ting Wu study director
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ginkgo biloba dispersible tablets, Donepezil and Ginkgo biloba dispersible tablets and Donepezil in people with Alzheimer's, run by The First Affiliated Hospital with Nanjing Medical University at 1 site 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 9 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ting Wu (18851122018, wuting80000@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scales to assess (time frame: change from baseline MMSE at 12weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2019.