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Rosiglitazone (Extended Release Tablets) As Adjunctive Therapy For Subjects With Mild To Moderate Alzheimer's Disease (REFLECT-2)

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ClinicalTrials.gov Identifier: NCT00348309
Recruitment Status : Completed
First Posted : July 4, 2006
Results First Posted : November 28, 2017
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Interventions: Drug: Rosiglitazone Extended Release 2mg
Drug: Rosiglitazone Extended Release 8mg
Other: Placebo
Other: Donepezil

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted on participants with mild to moderate Alzheimer’s disease(AD), who received donepezil for at least 6 months and who received a stable dose of donepezil for at least 2 months immediately before study entry from 06 July 2006 to 28 January 2009 across 228 centers of 19 countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 1496 participants were randomized for the study, out of which seventeen participants did not receive study medication. A total of 1479 were included in the Safety population.

Reporting Groups
  Description
Placebo Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
2mg Rosiglitazone Extended Release Participants received rosiglitazone extended release 2 milligram (mg) tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
8mg Rosiglitazone Extended Release Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.

Participant Flow:   Overall Study
    Placebo   2mg Rosiglitazone Extended Release   8mg Rosiglitazone Extended Release
STARTED   496   494   489 
COMPLETED   362   396   346 
NOT COMPLETED   134   98   143 
Adverse Event                56                28                63 
Lost to Follow-up                6                7                4 
Protocol Violation                7                12                7 
Withdrawal by Subject                33                37                40 
Non-compliance                8                6                8 
Death of caregiver                1                0                1 
Lack of insight, dementia                1                0                0 
Wrong bottle allocated                1                0                0 
Caregiver sick                1                0                0 
Use of prohibited medication                5                2                2 
Caregiver withdrawal                3                0                7 
Unable to complete ET visit                1                0                0 
PI closing medical practice                1                0                0 
Principal investigator's decision                1                0                0 
No disponibility of medication                1                0                0 
Worsened neurodegenerative disease                1                0                0 
Cognitive and behaviour worsening                2                0                0 
Worsening of alzheimer                1                0                1 
Did not appear in time for Visit 3                1                0                0 
Participant died                2                1                1 
Decision of sponsor                1                0                0 
Ineffectiveness of treatment                0                1                0 
A foul of exclusion criteria                0                1                0 
Participant was hospitalized                0                1                0 
Sponsor refuseal                0                1                1 
Forgot often medication                0                1                0 
Medical Monitor decision                0                0                1 
Increased dose of Aricept                0                0                1 
Site closure                0                0                1 
Adverse event not attended                0                0                1 
ECG abnormal                0                0                2 
Cardiologist recommendations                0                0                1 
HCV career                0                0                1 



  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
Placebo Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
2mg Rosiglitazone Extended Release Participants received rosiglitazone extended release 2 milligram (mg) tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
8mg Rosiglitazone Extended Release Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
Total Total of all reporting groups

Baseline Measures
   Placebo   2mg Rosiglitazone Extended Release   8mg Rosiglitazone Extended Release   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 496   494   489   1479 
Age 
[Units: Years]
Mean (Standard Deviation) 		 74.2  (7.95)   74.5  (8.06)   74.4  (7.83)   74.4  (7.94) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		       
Female      304  61.3%      286  57.9%      305  62.4%      895  60.5% 
Male      192  38.7%      208  42.1%      184  37.6%      584  39.5% 
Race/Ethnicity, Customized 
[Units: Participants]
 		       
Hispanic or Latino   97   86   82   265 
Not Hispanic or Latino   399   408   407   1214 


  Outcome Measures

1.  Primary:   Change From Baseline in Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) Total Score at Week 48   [ Time Frame: Baseline (Week 0) and Week 48 ]
  Show Outcome Measure 1

2.  Primary:   Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) at Week 48 for APOE E4   [ Time Frame: Baseline (Week 0) and Week 48 ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score   [ Time Frame: Baseline (Week 0), Week 8, 16, 24 and 48 ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score   [ Time Frame: Baseline (Week 0), Week 8, 16, 24 and 48 ]
  Show Outcome Measure 4

5.  Secondary:   Change From Screening in Mini Mental State Examination (MMSE) Total Score   [ Time Frame: Screening (Week -4) and Week 48 ]
  Show Outcome Measure 5

6.  Secondary:   Change From Baseline in the Domains of the Resource Utilization in Dementia Scale (RUD)   [ Time Frame: Baseline (Week 0), Week 12, 24, 36 and 48 ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline in European Quality of Life-5 Dimensions Proxy Version (EQ-5D Proxy) Scale Total Score Assessed by Thermometer (Visual Analog Scale [VAS]) and Utility   [ Time Frame: Baseline (Week 0), Week 12, 36 and 48 ]
  Show Outcome Measure 7

8.  Secondary:   Change From Baseline in ADAS-Cog Total Score for Observed Cases at Weeks 8, 16, 24, 36 and 48   [ Time Frame: Baseline (Week 0), Week 8, 16, 24, 36 and 48 ]
  Show Outcome Measure 8

9.  Secondary:   Change From Baseline in CDR-SB Score for Observed Cases at Weeks 12, 24, 36 and 48   [ Time Frame: Baseline (Week 0), Week 12, 24, 36 and 48 ]
  Show Outcome Measure 9

10.  Secondary:   Change in ADAS-Cog Total Score for Observed Cases at Week 54 Compared to Week 48   [ Time Frame: Week 48 and 54 ]
  Show Outcome Measure 10

11.  Secondary:   Change in CDR-SB Total Score at Week 54 Compared to Week 48   [ Time Frame: Week 48 and 54 ]
  Show Outcome Measure 11

12.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 48   [ Time Frame: Baseline (Week 0) and Week 48 ]
  Show Outcome Measure 12

13.  Secondary:   Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Up to Week 54 ]
  Show Outcome Measure 13

14.  Secondary:   Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP)   [ Time Frame: Baseline (Week 0), Week 4, 8, 12, 16, 24, 36, 48 and 56 ]
  Show Outcome Measure 14

15.  Secondary:   Mean Change From Baseline in Heart Rate   [ Time Frame: Baseline (Week 0), Week 4, 8, 12, 16, 24, 36, 48 and 56 ]
  Show Outcome Measure 15

16.  Secondary:   Mean Change From Baseline in Weight   [ Time Frame: Baseline (Week 0), Week 4, 8, 12, 16, 24, 36, 48 and 56 ]
  Show Outcome Measure 16

17.  Secondary:   Change From Baseline in Hemoglobin Values   [ Time Frame: Baseline (Week 0), Week 4, 16, 36 and 48 ]
  Show Outcome Measure 17

18.  Secondary:   Change From Baseline in Hematocrit Values   [ Time Frame: Baseline (Week 0), Week 4, 8, 12, 16, 36 and 48 ]
  Show Outcome Measure 18

19.  Secondary:   Mean Change From Baseline in Short Term Memory Assessment Score   [ Time Frame: Baseline (Week 0), Week 8, 16, 24, 36, 48 and 56 ]
  Show Outcome Measure 19

20.  Secondary:   Change From Baseline in HbA1c at Week 12, Week 24 and Week 36   [ Time Frame: Baseline (Week 0) and Week 12, 24 and 36 ]
  Show Outcome Measure 20

21.  Secondary:   Number of Participants With Laboratory Potential Clinical Concern (PCC) Values   [ Time Frame: Baseline (Week 0), Week 4, 8, 12, 16, 24, 36, 48 and 56 ]
  Show Outcome Measure 21

22.  Secondary:   Change From Baseline in Alzheimer’s Carer Quality of Life Instrument (ACQLI) Total Score   [ Time Frame: Baseline (Week 0), Week 12, 36 and 48 ]
  Show Outcome Measure 22


  Serious Adverse Events


  Other Adverse Events


  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