OsteoarthritisPhase 3DAPOCDNCT02927522
Donepezil Attenuate Postoperative Cognitive Dysfunction
A Phase 3 study testing Donepezil in people with Osteoarthritis and Femoral Head Necrosis, run by RenJi Hospital at 1 site in China.
Trial summary
Postoperative cognitive dysfunction (POCD) occurs mainly in aged patients. POCD may increase the mortality and morbidity. However, the mechanism of POCD is not clear yet and no effective therapy method was proved. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Femoral Head Necrosis, Rheumatoid Arthritis
- What is being tested?
- Donepezil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 550 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to Dec 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elder than 60 years old
- Speak Chinese Mandarin
- Those who will undergo knee or hip replacement
- Signed the inform consent
- American Society of Anesthesiologists classification I to III
Who cannot join
- Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis;
- existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24;
- several audition or vision disorder;
- unwillingness to comply with the protocol or procedures.
- Can not communicated with Chinese Mandarin
- Existing bradycardiac arrhythmia（Heart rate <60 bpm for any reasons）
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- Existing gastrointestinal ulcer
- Existing urinary incontinence
- Existing asthma or chronic obstructive pulmonary disease
- Allegory to Donepezil
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
Shanghai, Shanghai Municipality, 200052
Xiaoxue Hu
About this study
Official title: Donepezil Attenuate Postoperative Cognitive Dysfunction in Aged Patients- A Multi-center, Case Control, Randomized Clinical Trail
Postoperative cognitive dysfunction (POCD) occurs mainly in aged patients. POCD may increase the mortality and morbidity. However, the mechanism of POCD is not clear yet and no effective therapy method was proved. According to our previous study, the central cholinergic system impaired by the anesthesia and surgery play a very important role in the POCD and donepezil an acetylcholinesterase inhibitor can prevent the POCD after isoflurane anesthesia in aged mice. Donepezil is a commercial medicine used for the Alzheimer Disease, which is tolerable and has minimal adverse events. In present study a multi-center randomized case control study was conducted and we hypothesized that donepezil attenuate the POCD.
- Conditions
- Osteoarthritis, Femoral Head Necrosis, Rheumatoid Arthritis
- Being tested
- Donepezil, Placebo
- Keywords
- Postoperative Cognitive Dysfunction, Donepezil, Hip replacement, Knee replacement, Postoperative delirium
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Postoperative Cognitive Complications, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonepezilDrug
Donepezil a cholinesterase inhibitor, 5mg(1 pill)/ day for 7 days Po, was administrated from the day before surgery.
PlaceboDrug
Placebo, 1 pill/ day for 7 days Po, was administrated from the day before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Placebo was administrated Receives: Drug: Placebo |
| Donepezil | Experimental | Donepezil (5mg/ day for 7 days) was administrated Receives: Drug: Donepezil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of POCD 7 days(or before leaving hospital ) after surgery
Measured: 7 days after surgery or before leaving hospital
The incidence of postoperative delirium after surgery
Measured: 1 to 7 days after surgery
Secondary outcomes (1)
POCD incidence 1 months after surgery
Measured: 1 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2016 (estimated)
- Study start1 Sep 2018
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
- Responsible party
- Principal investigator, diansan su, RenJi Hospital
- Investigators
- Diansan Su, M.D., Ph.D., Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927522
- Sponsor's protocol ID
- RJ20161003
- Acronym
- DAPOCD
- Status last verified
- Jan 2020
- First submitted
- 5 Oct 2016
- Last updated
- 30 Jan 2020
- 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 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Donepezil Attenuate Postoperative Cognitive Dysfunction in Aged Patients- A Multi-center, Case Control, Randomized Clinical Trail
- ClinicalTrials.gov ID
- NCT02927522
- Acronym / sponsor ID
- DAPOCD / RJ20161003
- Conditions
- Osteoarthritis, Femoral Head Necrosis, Rheumatoid Arthritis
- Keywords
- Postoperative Cognitive Dysfunction, Donepezil, Hip replacement, Knee replacement, Postoperative delirium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 7 Oct 2016 (estimated)
- 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.
Postoperative cognitive dysfunction (POCD) occurs mainly in aged patients. POCD may increase the mortality and morbidity. However, the mechanism of POCD is not clear yet and no effective therapy method was proved. According to our previous study, the central cholinergic system impaired by the anesthesia and surgery play a very important role in the POCD and donepezil an acetylcholinesterase inhibitor can prevent the POCD after isoflurane anesthesia in aged mice. Donepezil is a commercial medicine used for the Alzheimer Disease, which is tolerable and has minimal adverse events. In present study a multi-center randomized case control study was conducted and we hypothesized that donepezil attenuate the POCD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: PlaceboPlacebo was administrated |
| Donepezil | Experimental | Drug: DonepezilDonepezil (5mg/ day for 7 days) was administrated |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Elder than 60 years old
- Speak Chinese Mandarin
- Those who will undergo knee or hip replacement
- Signed the inform consent
- American Society of Anesthesiologists classification I to III
Key exclusion criteria (10 listed)
- Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis;
- existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24;
- several audition or vision disorder;
- unwillingness to comply with the protocol or procedures.
- Can not communicated with Chinese Mandarin
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 |
|---|---|---|
| DonepezilDonepezil a cholinesterase inhibitor, 5mg(1 pill)/ day for 7 days Po, was administrated from the day before surgery. | Drug | Donepezil |
| PlaceboPlacebo, 1 pill/ day for 7 days Po, was administrated from the day before surgery. | Drug | Control |
Primary outcome
The incidence of POCD 7 days(or before leaving hospital ) after surgery
Time frame: 7 days after surgery or before leaving hospital
The incidence of postoperative delirium after surgery
Time frame: 1 to 7 days after surgery
1 secondary outcome
POCD incidence 1 months after surgery
Time frame: 1 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
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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.
Diansan Su, M.D., Ph.D. principal investigator
RenJi Hospital
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 Donepezil in people with Osteoarthritis and Femoral Head Necrosis, run by RenJi Hospital 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 5 inclusion and 10 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 30 Jan 2020. 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 Diansan Su, M.D., Ph.D. (+8618616514088, diansansu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of POCD 7 days(or before leaving hospital ) after surgery (time frame: 7 days after surgery or before leaving hospital). The study lists 2 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 30 Jan 2020.