Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Effect of EGb761® on Brain Glucose Metabolism in Three Groups of Elderly Defined by Cognitive Functions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00814346
First received: December 23, 2008
Last updated: February 26, 2016
Last verified: February 2016
Results First Received: September 11, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Alzheimer's Disease
Cognitive Impairment
Interventions: Drug: EGb761®
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

A total of 63 participants were screened of which 49 subjects were randomised to either EGb761 and Placebo treatment groups (double-blind period).

The 49 randomised subjects consisted of three groups of elderly subjects: Cognitively normal elderly (CNE), Memory Complaint (MC) and Alzheimer’s Disease (AD).


Reporting Groups
  Description
EGb761 120 mg EGb761 120 mg tablet twice a day for 4 weeks (Double-blind phase) for CNE, MC, and AD patients and 17 months (Open phase) for CNE and MC patients
Placebo Placebo 1 tablet twice a day for 4 weeks CNE, MC, and AD patients

Participant Flow for 2 periods

Period 1:   Double-blind Phase (4 Weeks)
    EGb761 120 mg   Placebo
STARTED   23   26 
CNE   10   13 
MC   10   11 
AD   3   2 
COMPLETED   23   23 
NOT COMPLETED   0   3 
Adverse Event                0                1 
Not otherwise specified                0                2 

Period 2:   Open Phase (17 Months)
    EGb761 120 mg   Placebo
STARTED   41 [1]   0 [2] 
CNE   21   0 
MC   20   0 
AD   0 [3]   0 
COMPLETED   31   0 
NOT COMPLETED   10   0 
Adverse Event                5                0 
Consent                2                0 
Lost to Follow-up                2                0 
Not otherwise specified                1                0 
[1] Open period was treated with EGB761®. 41 subjects accepted follow-up open period(21 in CNE,20 in MC)
[2] This was an open period, without placebo arm, the number of subject on placebo is 0.
[3] Open period was not proposed to AD subjects.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
EGb761 120 mg EGb761 120 mg tablet twice a day for 4 weeks (Double-blind phase) for CNE, MC, and AD patients and 17 months (Open phase) for CNE and MC patients
Placebo Placebo 1 tablet twice a day for 4 weeks CNE, MC, and AD patients
Total Total of all reporting groups

Baseline Measures
   EGb761 120 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 23   26   49 
Age 
[Units: Years]
Mean (Standard Deviation)
 75.1  (6.2)   76.6  (5.3)   75.85  (5.25) 
Gender 
[Units: Participants]
     
Female   15   17   32 
Male   8   9   17 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 24.49  (4.46)   25.03  (4.40)   24.76  (4.43) 
Educational Level 
[Units: Participants]
     
Level 1: Primary only   1   0   1 
Level 2: School certificate   2   5   7 
Level 3: Completed secondary   3   6   9 
Level 4: University   17   15   32 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Brain Glucose Metabolism Measured Using 18-Fluorodeoxyglucose Positron Emission Tomography (18FDG-PET)   [ Time Frame: From Baseline (Month 0) to Week 4 (Month 1) - Double blind phase ]

2.  Secondary:   Change in Brain Glucose Metabolism in the MC and CNE Groups   [ Time Frame: From Baseline (Month 0) to Month 18 ]

3.  Secondary:   Change in Cognitive Tests-Clinical Dementia Rating (CDR) Score in MC and CNE Groups   [ Time Frame: From Baseline (Month 0) to Month 9 ]

4.  Secondary:   Change in Cognitive Tests-Geriatric Depression Scale (GDS) Score in MC and CNE Groups   [ Time Frame: From Baseline (Month 0) to Month 9 ]

5.  Secondary:   Change in Cognitive Tests-Verbal Fluency in MC and CNE Groups   [ Time Frame: From Baseline (Month 0) to Month 9 ]

6.  Secondary:   Change in Cognitive Tests-Mini Mental Status Examination (MMSE) Score in MC and CNE Groups   [ Time Frame: From Baseline (Month 0) to Month 9 ]

7.  Secondary:   Change in Cognitive Tests-Clock Drawing Test Score in MC and CNE Groups   [ Time Frame: From Baseline (Month 0) to Month 9 ]

8.  Secondary:   Change in Cognitive Tests-Cube Drawing Test Score in MC and CNE Groups   [ Time Frame: From Baseline (Month 0) to Month 9 ]

9.  Secondary:   Change in Cognitive Tests in MC and CNE Groups - Total Immediate Recall and Delayed Recall Scores of the Free and Cued Selective Reminding Test (FCSRT)   [ Time Frame: From Baseline (Month 0) to Month 9 ]

10.  Secondary:   Change in Cognitive Tests-Age-Adjusted Logical Memory (MEM III) in MC and CNE Groups   [ Time Frame: From Baseline (Month 0) to Month 9 ]

11.  Secondary:   Change in Cognitive Tests-Age-Adjusted Wechsler Adult Intelligence Scale (WAIS) in MC and CNE Groups   [ Time Frame: From Baseline (Month 0) to Month 9 ]

12.  Secondary:   Change in Cognitive Tests-Time to Perform Trail Making Test (TMT) in MC and CNE Groups   [ Time Frame: From Baseline (Month 0) to Month 9 ]

13.  Secondary:   Number of Subjects Conversion to Alzheimer’s Dementia Diagnosed According to the DSM IV (Diagnostic of Dementia)   [ Time Frame: At Month 9 ]

14.  Secondary:   Number of Subjects Conversion to Alzheimer’s Dementia Diagnosed According to NINCDS-ADRDA (Diagnostic of Alzheimer’s)   [ Time Frame: At Month 9 ]

15.  Secondary:   Change in Cognitive Tests-CDR Score in MC and CNE Groups   [ Time Frame: From Baseline (Month 0) to Month 18 ]

16.  Secondary:   Change in Cognitive Tests-GDS Score in MC and CNE Groups   [ Time Frame: From Baseline (Month 0) to Month 18 ]

17.  Secondary:   Change in Cognitive Tests-Verbal Fluency in MC and CNE Groups   [ Time Frame: From Baseline (Month 0) to Month 18 ]

18.  Secondary:   Change in Cognitive Tests-MMSE Score in MC and CNE Groups   [ Time Frame: From Baseline (Month 0) to Month 18 ]

19.  Secondary:   Change in Cognitive Tests-Clock Drawing Test Score in MC and CNE Groups   [ Time Frame: From Baseline (Month 0) to Month 18 ]

20.  Secondary:   Change in Cognitive Tests-Cube Drawing Test Score in MC and CNE Groups   [ Time Frame: From Baseline (Month 0) to Month 18 ]

21.  Secondary:   Change in Cognitive Tests in MC and CNE Groups - Total Immediate Recall and Delayed Recall Scores of FCSRT   [ Time Frame: From Baseline (Month 0) to Month 18 ]

22.  Secondary:   Change in Cognitive Tests-Age-Adjusted Logical Memory (MEM III) in MC and CNE Groups   [ Time Frame: From Baseline (Month 0) to Month 18 ]

23.  Secondary:   Change in Cognitive Tests-Age-Adjusted WAIS in MC and CNE Groups   [ Time Frame: From Baseline (Month 0) to Month 18 ]

24.  Secondary:   Change in Cognitive Tests-Time to Perform TMT in MC and CNE Groups   [ Time Frame: From Baseline (Month 0) to Month 18 ]

25.  Secondary:   Number of Subjects Conversion to Alzheimer’s Dementia Diagnosed According to the DSM IV (Diagnostic of Dementia)   [ Time Frame: At Month 18 ]

26.  Secondary:   Number of Subjects Conversion to Alzheimer’s Dementia Diagnosed According to NINCDS-ADRDA (Diagnostic of Alzheimer’s)   [ Time Frame: At Month 18 ]

27.  Secondary:   Incidence of Adverse Events (AEs)   [ Time Frame: Up to Month 18 ]

28.  Secondary:   Change in Brain Morphology in the MC and CNE Groups as Determined by the Change in Voxel Size   [ Time Frame: From Baseline (Month 0) to Month 18 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Medical Director, Neurology
Organization: Ipsen
phone: clinical.trials@ipsen.com
e-mail: clinical.trials@ipsen.com



Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00814346     History of Changes
Other Study ID Numbers: 2-39-00240-134
2007-005377-63 ( EudraCT Number )
Study First Received: December 23, 2008
Results First Received: September 11, 2015
Last Updated: February 26, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)