A Phase 3 interventional study of Octohydroaminoacridine Succinate and Aricept in Alzheimer Disease, sponsored by Shanghai Mental Health Center. Status unknown at 1 site in China. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-10-22.
Sponsored by Shanghai Mental Health Center · Phase 3, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 260 studies in Alzheimer Disease with a site in China — 150 open to participants now, 162 under way, 21 of them phase 3. Alzheimer Disease · China.
Among the 260 studies in Alzheimer Disease with a site in China, this one is the 25th largest by planned enrollment of the 176 interventional ones that give a count, is one of 9 that started in 2017, is one of 33 in phase 3, and was the 36th registered.
3,968 studies on the registry are indexed under Alzheimer Disease; 928 are open to participants now.
Browse Alzheimer Disease studies →150 of the 260 studies in Alzheimer Disease with a site in China are open now. Recruiting first, the newest first:
Fudan University · Sites in China
Ages 18+
Hoffmann-La Roche · Sites in China, United States, Argentina and 7 more countries
Ages 55–80
Eli Lilly and Company · Sites in China, United States, Japan
Ages 18–85 · Healthy volunteers
Anhui Medical University · Sites in China
Ages 45–84
JYAMS PET Research & Development Limited · Sites in China
Ages 50+ · Healthy volunteers
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 643 Alzheimer Disease studies recruiting now, 284 (44%) set no upper age limit and 55 (9%) stop at 75 or younger; 34 take children under 18; 285 take healthy volunteers.
This study: 50 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
260 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 31 · Phase 2 28 · Phase 3 36 · Phase 4 11
First in 2000; this study’s year is marked. 9 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 600 is above the median of 70 across 3,021 interventional studies indexed under Alzheimer Disease.
Median enrollment 100 across the 176 interventional studies, 566 across the 84 observational. Of the 65 that completed or were terminated, 16 (25%) have results posted.
This tab as a report to print or save as PDF → With an account.
68 of 260 have an industry lead sponsor. The 10 most frequent:
Shanghai Mental Health Center is the lead sponsor of 272 studies on the registry; 91 are open to participants now.
Shanghai Mental Health Center has 8 studies filed under Alzheimer Disease — fewer than ten, so there is no comparison to draw.
44 of the studies in Alzheimer Disease with a site in China that are under way reach primary completion within a year, 8 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06585787Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyA Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4) | 2026-11-24 |
| NCT07422857Phase 3JYAMS PET Research & Development LimitedEvaluate the Use of [18F]-APN-1607 PET in Subjects With AD-related Cognitive Impairment and Subjects With Normal Cognitive Function | 2026-12-01 |
| NCT06126224Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyA Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2) | 2026-12-09 |
| NCT03887455Phase 3Eisai Inc.A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease | 2026-12-31 |
| NCT07323914Phase 3Xuanwu Hospital, BeijingClinical Analgesic Management in Dementia | 2027-01-01 |
Add all 44 to your calendar (.ics) → With an account.
Among the 260 studies in Alzheimer Disease with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Octohydroaminoacridine Succinate Tablet 4mg P.O. tid
Drug: Octohydroaminoacridine Succinate
Aricept 5mg/day P.O.
Drug: Aricept
Placebo P.O. tid
Drug: Placebos
Octohydroaminoacridine Succinate Tablet:4mg P.O. tid
Aricept 5mg/day, P.O.
Placebo Tablet: P.O. tid
Alzheimer's Disease Assessment Scale-Cognitive section (ADAS-Cog)
The change of ADAS-Cog from baseline to endpoint among three arms.
Time frame: 26 weeks double-blind study and 28 weeks extention study
Clinician's Interview Based Impression of Change - plus (CIBIC+)
The change of CIBIC+ from baseline to endpoint among three arms.
Time frame: 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.
Time frame: 26 weeks double-blind study and 28 weeks extention study
Neuropsychiatric Inventory (NPI)
The change of NPI from baseline to endpoint among three arms.
Time frame: 26 weeks double-blind study and 28 weeks extention study
Plan to share: No — Other researchers should apply to the sponsor.
No publications or documents are linked to this record.
Started Aug 2017 (actual). Primary completion is estimated for Sep 2020, 37 months after the start.
Of 101 phase 3 interventional studies under Alzheimer Disease, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 73. This study's planned 37 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shanghai Mental Health Center →