Alzheimer DiseasePhase 3NCT03283059
Octohydroaminoacridine Succinate Tablet for Mild-to-Moderate Alzheimer's Disease
A Phase 3 study testing Octohydroaminoacridine Succinate and Aricept in people with Alzheimer Disease, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
Inhibition of acetylcholinesterase has been a effective treatment for Alzheimer's disease. Octohydroaminoacridine, a new acetylcholinesterase inhibitor, is a potential treatment for Alzheimer's disease. 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?
- Octohydroaminoacridine Succinate and Aricept
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 16 Aug 2017to 16 Feb 2021
- Phase
- Phase 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
- Age 50-85 years (including 50 and 85 years old), male or female;
- Diagnose probable AD in accordance with the National Institute Aging and Alzheimer's Association (NIA-AA) (2011);
- Mild-to-moderate AD patients, MMSE 11-26 (including 11 and 26, primary school education subjects from 11 to 22);
- Hachinski Incheinic Score (HIS) less than 4 points;
- Hamilton depression scale /17 Version (HAMD) score less than 10 points;
- Memory decline at least 12 months, and the decline is progressive;
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- Brain MRI examination was done within 6 months before screening;
- Neurological examination had no obvious signs (except due to AD disease or peripheral injury);
- Females were postmenopausal (menopause beyond 24 weeks), or accepted the surgical sterilization, or women of childbearing age agreed to take effective contraceptive measures during the study. Women of childbearing age or menopausal time shorter than 24 weeks must do the urine pregnancy test and results to be negative during the screening period;
- Subjects should have stable and reliable caregivers, or have frequent contact with caregivers (at least 4 days per week, at least 2 hours per day), caregivers will help patients to participate in the study. Caregivers must accompany the subjects in the study visit to provide valuable information for the NPI, ADCS-ADL and CIBIC-plus scales assessments;
- Subjects have at least primary school education level, and have the ability to complete the determination of cognitive ability assessments and other tests;
- The participants and legal guardian must sign informed consent.
Who cannot join
- Brain MRI examination showed significant focal lesions, moderate-to-severe white matter lesions, and key parts lacunar infarction such as the thalamus, hippocampus, entorhinal cortex, cortical and subcortical gray matter nuclei;
- Other type of dementia except AD;
- Suffered from nervous system diseases (including stroke, optic myelopathy, Parkinson's disease, epilepsy, etc);
- Psychotic patients, according to the DSM-5 criteria, include schizophrenia or other psychiatry disorders, bipolar disorder, major depression disorder, or delirium;
- Abnormal laboratory test results: HBsAg and HBeAg and/or HbcAb positive and active stage of hepatitis B, liver function (ALT, AST) more than 1.2 times of the upper limit of the normal range, Cr exceeds the upper limit of normal, white blood cell count less than 4 x 109/L or platelet less than 100 x 109/L, hemoglobin less than 100g/L, blood glucose concentration of diabetic subjects (random) is more than 13.9mmol/L;
- Systolic pressure was more than 160mmHg or less than 90mmHg, diastolic blood pressure was more than 100mmHg or less than 60mmHg;
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- With unstable or serious heart, lung, liver, kidney and hematopoietic system diseases (including unstable angina, myocardial infarction, uncontrolled asthma, gastric cancer, et al), or resting heart rate after 10 minutes of rest was less than 60 BPM, or QTc (QTc B (Bazett's correction value) or QTc F (Fridericia's correction value)) was equal or greater than 450msec, or with bundle branch block, the QTc B or QTc F was equal or greater than 480msec, or the researchers estimate there were abnormal EKG results which cannot be randomized to the study;
- There was uncorrected of visual and auditory disturbances, and neuropsychological tests and scale assessments cannot be completed by the subject;
- Subject was currently using Alzheimer's disease drugs and cannot be terminate the treatment;
- Subjects that cannot take the test drug according to the prescription should be excluded;
- Alcohol abuse or drug abuse;
- Pregnant or lactating women;
- Participated in other clinical pharmacological tests within 30 days before screening visit;
- The researchers believe that the subject was impossible to complete the study;
- Participants were employees of the study and immediate family members, employees of CRO company or sponsor and their immediate family members.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Shifu Xiao, M.D., Ph.D., +86 21 64387250 ext. 73441, xiaoshifu@msn.com
Tao Wang, M.D., Ph.D., +86 18017311279, wtshhwy@163.com
About this study
Official title: Phase III Trial of Octohydroaminoacridine Succinate Tablet for Mild-to-Moderate Alzheimer's Disease: a 26 Weeks, Randomized, Double-blind, Double-dummy, Placebo- and Positive- Parallel Controlled and Extended Single Arm to 54 Weeks Multicentre Study
Inhibition of acetylcholinesterase has been a effective treatment for Alzheimer's disease. Octohydroaminoacridine, a new acetylcholinesterase inhibitor, is a potential treatment for Alzheimer's disease. The investigators conducted a 26 weeks, randomized, double-blind, double-dummy, placebo- and positive- parallel controlled and extended single arm to 54 weeks multicentre phase III clinical trial to investigate the effects of octohydroaminoacridine in patients with mild-to-moderate Alzheimer's disease. Patients were randomized to receive placebo thrice daily, or octohydroaminoacridine 4 mg/TID or ARICEPT 5mg/QD.
- Conditions
- Alzheimer Disease
- Being tested
- Octohydroaminoacridine Succinate, Aricept, Placebos
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octohydroaminoacridine SuccinateDrug
Octohydroaminoacridine Succinate Tablet:4mg P.O. tid
AriceptDrug
Aricept 5mg/day, P.O.
PlacebosDrug
Placebo Tablet: P.O. tid
| Study group | Role | What they receive |
|---|---|---|
| Octohydroaminoacridine Succinate Tablet | Experimental | Octohydroaminoacridine Succinate Tablet 4mg P.O. tid Receives: Drug: Octohydroaminoacridine Succinate |
| Aricept | Active comparator | Aricept 5mg/day P.O. Receives: Drug: Aricept |
| Placebo | Placebo comparator | Placebo P.O. tid Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's Disease Assessment Scale-Cognitive section (ADAS-Cog)
The change of ADAS-Cog from baseline to endpoint among three arms.
Measured: 26 weeks double-blind study and 28 weeks extention study
Secondary outcomes (3)
Clinician's Interview Based Impression of Change - plus (CIBIC+)
The change of CIBIC+ from baseline to endpoint among three arms.
Measured: 26 weeks double-blind study and 28 weeks extention study
Activities of Daily Living (ADL)
The change of ADL from baseline to endpoint among three arms.
Measured: 26 weeks double-blind study and 28 weeks extention study
Neuropsychiatric Inventory (NPI)
The change of NPI from baseline to endpoint among three arms.
Measured: 26 weeks double-blind study and 28 weeks extention study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start16 Aug 2017
- Primary completion16 Sep 2020 (estimated)
- Study completion16 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Changchun Huayang High-tech Co., Ltd, Jiangsu Sheneryang High-tech Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Shifu Xiao, M.D., Ph.D., Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03283059
- Sponsor's protocol ID
- OHAAS-III
- Status last verified
- Oct 2019
- First submitted
- 12 Sep 2017
- Last updated
- 22 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Other researchers should apply to the sponsor.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Trial of Octohydroaminoacridine Succinate Tablet for Mild-to-Moderate Alzheimer's Disease: a 26 Weeks, Randomized, Double-blind, Double-dummy, Placebo- and Positive- Parallel Controlled and Extended Single Arm to 54 Weeks Multicentre Study
- ClinicalTrials.gov ID
- NCT03283059
- Acronym / sponsor ID
- OHAAS-III
- Conditions
- Alzheimer Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Changchun Huayang High-tech Co., Ltd, Jiangsu Sheneryang High-tech Co., Ltd
- Study start
- 16 Aug 2017 (actual)
- Primary completion
- 16 Sep 2020 (estimated)
- Study completion
- 16 Feb 2021 (estimated)
- First posted
- 14 Sep 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.
Inhibition of acetylcholinesterase has been a effective treatment for Alzheimer's disease. Octohydroaminoacridine, a new acetylcholinesterase inhibitor, is a potential treatment for Alzheimer's disease. The investigators conducted a 26 weeks, randomized, double-blind, double-dummy, placebo- and positive- parallel controlled and extended single arm to 54 weeks multicentre phase III clinical trial to investigate the effects of octohydroaminoacridine in patients with mild-to-moderate Alzheimer's disease. Patients were randomized to receive placebo thrice daily, or octohydroaminoacridine 4 mg/TID or ARICEPT 5mg/QD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Octohydroaminoacridine Succinate Tablet | Experimental | Drug: Octohydroaminoacridine SuccinateOctohydroaminoacridine Succinate Tablet 4mg P.O. tid |
| Aricept | Active comparator | Drug: AriceptAricept 5mg/day P.O. |
| Placebo | Placebo comparator | Drug: PlacebosPlacebo P.O. tid |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 50-85 years (including 50 and 85 years old), male or female;
- Diagnose probable AD in accordance with the National Institute Aging and Alzheimer's Association (NIA-AA) (2011);
- Mild-to-moderate AD patients, MMSE 11-26 (including 11 and 26, primary school education subjects from 11 to 22);
- Hachinski Incheinic Score (HIS) less than 4 points;
- Hamilton depression scale /17 Version (HAMD) score less than 10 points;
Key exclusion criteria (15 listed)
- Brain MRI examination showed significant focal lesions, moderate-to-severe white matter lesions, and key parts lacunar infarction such as the thalamus, hippocampus, entorhinal cortex, cortical and subcortical gray matter nuclei;
- Other type of dementia except AD;
- Suffered from nervous system diseases (including stroke, optic myelopathy, Parkinson's disease, epilepsy, etc);
- Psychotic patients, according to the DSM-5 criteria, include schizophrenia or other psychiatry disorders, bipolar disorder, major depression disorder, or delirium;
- Abnormal laboratory test results: HBsAg and HBeAg and/or HbcAb positive and active stage of hepatitis B, liver function (ALT, AST) more than 1.2 times of the upper limit of the normal range, Cr exceeds the upper limit of normal, white blood cell count less than 4 x 109/L or platelet less than 100 x 109/L, hemoglobin less than 100g/L, blood glucose concentration of diabetic subjects (random) is more than 13.9mmol/L;
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 |
|---|---|---|
| Octohydroaminoacridine SuccinateOctohydroaminoacridine Succinate Tablet:4mg P.O. tid | Drug | Octohydroaminoacridine Succinate Tablet |
| AriceptAricept 5mg/day, P.O. | Drug | Aricept |
| PlacebosPlacebo Tablet: P.O. tid | Drug | Placebo |
Primary outcome
Alzheimer's Disease Assessment Scale-Cognitive section (ADAS-Cog)
Time frame: 26 weeks double-blind study and 28 weeks extention study
The change of ADAS-Cog from baseline to endpoint among three arms.
3 secondary outcomes
Clinician's Interview Based Impression of Change - plus (CIBIC+)
Time frame: 26 weeks double-blind study and 28 weeks extention study
Activities of Daily Living (ADL)
Time frame: 26 weeks double-blind study and 28 weeks extention study
Neuropsychiatric Inventory (NPI)
Time frame: 26 weeks double-blind study and 28 weeks extention study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- Individual participant dataSharing planned: No. Other researchers should apply to the sponsor.
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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.
Shifu Xiao, M.D., Ph.D. principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Octohydroaminoacridine Succinate and Aricept in people with Alzheimer Disease, run by Shanghai Mental Health Center 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 12 inclusion and 15 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 22 Oct 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. 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 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 Shifu Xiao, M.D., Ph.D. (+86 21 64387250 ext. 73441, xiaoshifu@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alzheimer's Disease Assessment Scale-Cognitive section (ADAS-Cog) (time frame: 26 weeks double-blind study and 28 weeks extention study). 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 22 Oct 2019.