Trial Outcomes & Findings for Raloxifene for Women With Alzheimer's Disease (NCT NCT00368459)
NCT ID: NCT00368459
Last Updated: 2015-04-02
Results Overview
ADAS-cog, change from baseline at 12 months, compared between treatment arms. The ADAS-cog is a neuropsychological battery commonly used in trials of AD patients. Error score range 0-70. For results below, positive change represents improvement/ better performance. For the primary outcome, as well as for secondary outcomes, the reported p-values reflect the calculated p-values.
COMPLETED
PHASE2
42 participants
12 months
2015-04-02
Participant Flow
Participant milestones
| Measure |
Raloxifene
oral raloxifene 120 mg once daily
raloxifene
|
Placebo
identical appearing oral placebo
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Raloxifene for Women With Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Raloxifene
n=21 Participants
oral raloxifene 120 mg once daily
raloxifene
|
Placebo
n=21 Participants
identical appearing oral placebo
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
78 years
STANDARD_DEVIATION 4.5 • n=99 Participants
|
74 years
STANDARD_DEVIATION 5.1 • n=107 Participants
|
76 years
STANDARD_DEVIATION 4.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
21 participants
n=107 Participants
|
42 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Intent-to-treat
ADAS-cog, change from baseline at 12 months, compared between treatment arms. The ADAS-cog is a neuropsychological battery commonly used in trials of AD patients. Error score range 0-70. For results below, positive change represents improvement/ better performance. For the primary outcome, as well as for secondary outcomes, the reported p-values reflect the calculated p-values.
Outcome measures
| Measure |
Raloxifene
n=21 Participants
oral raloxifene 120 mg once daily
raloxifene
|
Placebo
n=21 Participants
identical appearing oral placebo
|
|---|---|---|
|
Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-cog)
|
-3.2 units on a scale
Standard Deviation 5.8
|
-3.5 units on a scale
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: 12 monthsGlobal rating of dementia severity, change from baseline at 12 months. Range 0-5. For results below, positive change represents improvement/ better performance.
Outcome measures
| Measure |
Raloxifene
n=21 Participants
oral raloxifene 120 mg once daily
raloxifene
|
Placebo
n=21 Participants
identical appearing oral placebo
|
|---|---|---|
|
Global Rating, Clinical Dementia Rating (CDR) Sum of Boxes
|
-2.6 units on a scale
Standard Deviation 1.8
|
-2.0 units on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 12 monthsADL scale from the Alzheimer's Disease Cooperative Study, change from baseline at 12 months. Range 0-78. For results below, positive change represents improvement/ better performance.
Outcome measures
| Measure |
Raloxifene
n=21 Participants
oral raloxifene 120 mg once daily
raloxifene
|
Placebo
n=21 Participants
identical appearing oral placebo
|
|---|---|---|
|
Function, Activities of Daily Living (ADL)
|
-9.1 units on a scale
Standard Deviation 9.4
|
-4.5 units on a scale
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: 12 monthsNeuropsychiatric Inventory, change from baseline at 12 months. Range 0-120. For results below, positive change represents improvement/ better performance.
Outcome measures
| Measure |
Raloxifene
n=21 Participants
oral raloxifene 120 mg once daily
raloxifene
|
Placebo
n=21 Participants
identical appearing oral placebo
|
|---|---|---|
|
Behavior
|
-2.3 units on a scale
Standard Deviation 7.8
|
-2.5 units on a scale
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: 12 monthsGlobal composite calculated as a weighted average of standardized scores of neuropsychological tests (weighted by the inverse intertest correlation matrix), change from baseline at 12 months. There is no theoretical maximum or minimum for this cognitive composite, with a score of 0 standardized units representing no change. For results below, positive change represents improvement/ better performance.
Outcome measures
| Measure |
Raloxifene
n=21 Participants
oral raloxifene 120 mg once daily
raloxifene
|
Placebo
n=21 Participants
identical appearing oral placebo
|
|---|---|---|
|
Cognitive (Neuropsychological)
|
-0.6 units on a scale
Standard Deviation 1.8
|
-1.1 units on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 6 monthsChange from baseline at 6 months, compared between groups. Error score range 0-70. For results below, positive change represents improvement/ better performance.
Outcome measures
| Measure |
Raloxifene
n=21 Participants
oral raloxifene 120 mg once daily
raloxifene
|
Placebo
n=21 Participants
identical appearing oral placebo
|
|---|---|---|
|
ADAS-cog
|
-0.7 units on a scale
Standard Deviation 4.2
|
-1.8 units on a scale
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: 6 monthsChange from baseline at 6 months, compared between groups. Range 0-5. For results below, positive change represents improvement/ better performance.
Outcome measures
| Measure |
Raloxifene
n=21 Participants
oral raloxifene 120 mg once daily
raloxifene
|
Placebo
n=21 Participants
identical appearing oral placebo
|
|---|---|---|
|
Clinical Dementia Rating, Sum of Boxes
|
-0.8 units on a scale
Standard Deviation 1.7
|
-1.0 units on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 6 monthsChange from baseline at 6 months, compared between groups. Range 0-78. For results below, positive change represents improvement/ better performance.
Outcome measures
| Measure |
Raloxifene
n=21 Participants
oral raloxifene 120 mg once daily
raloxifene
|
Placebo
n=21 Participants
identical appearing oral placebo
|
|---|---|---|
|
Function, Activities of Daily Living
|
-6.9 units on a scale
Standard Deviation 6.7
|
-0.3 units on a scale
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: 6 monthsNeuropsychiatric Inventory, change from baseline at 6 months, compared between groups. Range 0-120. For results below, positive change represents improvement/ better performance.
Outcome measures
| Measure |
Raloxifene
n=21 Participants
oral raloxifene 120 mg once daily
raloxifene
|
Placebo
n=21 Participants
identical appearing oral placebo
|
|---|---|---|
|
Behavior
|
-0.7 units on a scale
Standard Deviation 5.6
|
-2.1 units on a scale
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: 6 monthsGlobal composite calculated as a weighted average of standardized scores of neuropsychological tests (weighted by the inverse intertest correlation matrix), change from baseline at 6 months. There is no theoretical maximum or minimum for this cognitive composite, with a score of 0 standardized units representing no change. For results below, positive change represents improvement/ better performance.
Outcome measures
| Measure |
Raloxifene
n=21 Participants
oral raloxifene 120 mg once daily
raloxifene
|
Placebo
n=21 Participants
identical appearing oral placebo
|
|---|---|---|
|
Cognition (Neuropsychological)
|
-0.5 units on a scale
Standard Deviation 1.5
|
-0.6 units on a scale
Standard Deviation 1.1
|
Adverse Events
Raloxifene
Placebo
Serious adverse events
| Measure |
Raloxifene
n=21 participants at risk
oral raloxifene 120 mg once daily
raloxifene
|
Placebo
n=21 participants at risk
identical appearing oral placebo
|
|---|---|---|
|
Gastrointestinal disorders
colon cancer
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
|
Nervous system disorders
agitation
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
|
Nervous system disorders
death
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
|
Nervous system disorders
hallucinations
|
0.00%
0/21
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
Other adverse events
| Measure |
Raloxifene
n=21 participants at risk
oral raloxifene 120 mg once daily
raloxifene
|
Placebo
n=21 participants at risk
identical appearing oral placebo
|
|---|---|---|
|
Renal and urinary disorders
urinary tract infection
|
14.3%
3/21 • Number of events 5
|
4.8%
1/21 • Number of events 1
|
|
General disorders
cold symptoms
|
14.3%
3/21 • Number of events 3
|
9.5%
2/21 • Number of events 2
|
|
General disorders
decreased appetite
|
14.3%
3/21 • Number of events 3
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
back pain
|
9.5%
2/21 • Number of events 2
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
arm or shoulder pain
|
9.5%
2/21 • Number of events 2
|
0.00%
0/21
|
|
Gastrointestinal disorders
diarrhea
|
9.5%
2/21 • Number of events 2
|
14.3%
3/21 • Number of events 3
|
|
Gastrointestinal disorders
nausea
|
9.5%
2/21 • Number of events 2
|
9.5%
2/21 • Number of events 2
|
|
Gastrointestinal disorders
abdominal pain
|
9.5%
2/21 • Number of events 2
|
4.8%
1/21 • Number of events 1
|
|
General disorders
sinusitis
|
4.8%
1/21 • Number of events 3
|
9.5%
2/21 • Number of events 4
|
|
Psychiatric disorders
hallucinations
|
0.00%
0/21
|
14.3%
3/21 • Number of events 3
|
|
Psychiatric disorders
anxiety
|
0.00%
0/21
|
9.5%
2/21 • Number of events 2
|
|
Psychiatric disorders
paranoia
|
0.00%
0/21
|
14.3%
3/21 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
4.8%
1/21 • Number of events 1
|
9.5%
2/21 • Number of events 2
|
|
Psychiatric disorders
agitation
|
0.00%
0/21
|
9.5%
2/21 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place