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Minocycline Attenuate Postoperative Cognitive Dysfunction and Delirium (MAPOCD)

Primary Purpose

Prostate Cancer, Carcinoma of the Rectum, Colon Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Minocycline
Placebo
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostate Cancer focused on measuring Minocycline, Postoperative cognitive dysfunction, Postoperative delirium

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

For the placebo and minocycline group;

Inclusion Criteria:

  1. Elder than 65 years old
  2. Speak Chinese Mandarin
  3. Those who will undergo major general surgery like colorectal cancer excision, major urinary surgery like radical prostatectomy and radical nephrectomy
  4. Signed the inform consent
  5. American Society of Anesthesiologists classification I to III

Exclusion Criteria:

  1. Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis;
  2. Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24;
  3. Severe audition or vision disorder;
  4. Unwillingness to comply with the protocol or procedures.
  5. Cannot communicated with Chinese Mandarin
  6. With severe skin disease
  7. Serious heart or liver or renal insufficiency patients
  8. Had surgery in the past 30 days
  9. Allergy to tetracycline or minocycline

For the health volunteers;

Inclusion Criteria:

  1. Elder than 65 years old
  2. Speak Chinese Mandarin
  3. Signed the inform consent
  4. No major disease health people

Exclusion Criteria:

  1. Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis;
  2. Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24;
  3. Severe audition or vision disorder;
  4. Unwillingness to comply with the protocol or procedures.
  5. Cannot communicated with Chinese Mandarin
  6. Drug abuse, alcoholism
  7. Serious heart or liver or renal insufficiency patients
  8. Had surgery in the past 30 days
  9. Plan to undergo surgery in the following 3 months.

Sites / Locations

  • ScalesRecruiting
  • Shanghai Pudong Hospital
  • Shanghai Pudong New Area Dongming Community Health Care CenterRecruiting
  • Shanghai Pudong New Area people's HopsitalRecruiting
  • Shanghai Tenth HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

No Intervention

Arm Label

Placebo

Minocycline

Volunteers

Arm Description

Placebo administered before surgery

Minocycline was administrated before surgery

Health people for calculate the incidence of POCD

Outcomes

Primary Outcome Measures

POCD incidence 7 days (or before leaving hospital) after surgery
POD incidence

Secondary Outcome Measures

POCD incidence 2 months after surgery

Full Information

First Posted
October 5, 2016
Last Updated
January 25, 2020
Sponsor
RenJi Hospital
Collaborators
Shanghai 10th People's Hospital, Pudong New Area People's Hospital, Shanghai Pudong Hospital, Shanghai Pudong New Aera Dongming Community Health Care Center
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1. Study Identification

Unique Protocol Identification Number
NCT02928692
Brief Title
Minocycline Attenuate Postoperative Cognitive Dysfunction and Delirium
Acronym
MAPOCD
Official Title
Minocycline Attenuate Postoperative Cognitive Dysfunction and Delirium: A Multicenter, Randomized, Double-Blind Clinical Trail
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
Collaborators
Shanghai 10th People's Hospital, Pudong New Area People's Hospital, Shanghai Pudong Hospital, Shanghai Pudong New Aera Dongming Community Health Care Center

4. Oversight

5. Study Description

Brief Summary
Postoperative cognitive dysfunction (POCD) and postoperative delirium occurs mainly in aged patients. POCD and POD may increase the mortality and morbidity. However, the mechanism of POCD is not clear yet and no effective therapy method was proved. According to previous study, the neuroinflammation is the main reason both for POCD and POD. Minocycline is a tetracycline derivative. Due to it's lipophilic structure, it is easy to pass through blood brain barrier and attenuate neuroinflammation. It's neuroprotective effects has been proven in many experimental animal models such as Alzheimer's disease, Huntington's disease and Parkinson's syndrome. In present study, the investigators hypothesized that minocycline would attenuate the incidence of POCD and POD in the aged patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Carcinoma of the Rectum, Colon Cancer, Renal Carcinoma
Keywords
Minocycline, Postoperative cognitive dysfunction, Postoperative delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered before surgery
Arm Title
Minocycline
Arm Type
Experimental
Arm Description
Minocycline was administrated before surgery
Arm Title
Volunteers
Arm Type
No Intervention
Arm Description
Health people for calculate the incidence of POCD
Intervention Type
Drug
Intervention Name(s)
Minocycline
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
POCD incidence 7 days (or before leaving hospital) after surgery
Time Frame
7 days (or before leaving hospital)
Title
POD incidence
Time Frame
1 to 5 days after surgery
Secondary Outcome Measure Information:
Title
POCD incidence 2 months after surgery
Time Frame
2 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
For the placebo and minocycline group; Inclusion Criteria: Elder than 65 years old Speak Chinese Mandarin Those who will undergo major general surgery like colorectal cancer excision, major urinary surgery like radical prostatectomy and radical nephrectomy Signed the inform consent American Society of Anesthesiologists classification I to III Exclusion Criteria: 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; Severe audition or vision disorder; Unwillingness to comply with the protocol or procedures. Cannot communicated with Chinese Mandarin With severe skin disease Serious heart or liver or renal insufficiency patients Had surgery in the past 30 days Allergy to tetracycline or minocycline For the health volunteers; Inclusion Criteria: Elder than 65 years old Speak Chinese Mandarin Signed the inform consent No major disease health people Exclusion Criteria: 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; Severe audition or vision disorder; Unwillingness to comply with the protocol or procedures. Cannot communicated with Chinese Mandarin Drug abuse, alcoholism Serious heart or liver or renal insufficiency patients Had surgery in the past 30 days Plan to undergo surgery in the following 3 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diansan Su, Doctor
Phone
18616514088
Email
diansansu@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Li, Master Degree Candidate
Phone
15216711923
Email
56428923@qq.com
Facility Information:
Facility Name
Scales
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diansan Su, Dr.
Phone
18616514088
Email
diansansu@yahoo.com
First Name & Middle Initial & Last Name & Degree
Hui Li, M.S.
Phone
15216711923
Email
56428923@qq.com
First Name & Middle Initial & Last Name & Degree
Diansan Su, Dr.
First Name & Middle Initial & Last Name & Degree
Hui Li, M.S.
Facility Name
Shanghai Pudong Hospital
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongwei Duan
Phone
189-1879-0035
Facility Name
Shanghai Pudong New Area Dongming Community Health Care Center
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shifen Zhang
Phone
13916517543
Facility Name
Shanghai Pudong New Area people's Hopsital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lizhi Li, M.D.
Phone
139-1768-2738
Email
Fmlilizhi@sina.com.cn
Facility Name
Shanghai Tenth Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shukun Fu, M.D.
Phone
13816343916
Email
shukunfu@163.com

12. IPD Sharing Statement

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Minocycline Attenuate Postoperative Cognitive Dysfunction and Delirium

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