Trial · NCT00368459

Raloxifene for Women With Alzheimer's Disease

NCT00368459, Phase 2, Completed, Stanford University; results first posted 2015-04-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Raloxifene for Women With Alzheimer's Disease. Trials, record NCT00368459. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00368459

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Raloxifene for Women With Alzheimer's Disease
NCT number: NCT00368459
Status: Completed
Phases: Phase 2
Enrollment: 42 participants, actual
Lead sponsor: Stanford University
Conditions: Alzheimer Disease
Interventions: raloxifene, Placebo
First posted: 2006-08-24
Last updated: 2015-04-02
Results first posted: 2015-04-02

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-cog)	12 months	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.
Secondary	Global Rating, Clinical Dementia Rating (CDR) Sum of Boxes	12 months	Global rating of dementia severity, change from baseline at 12 months. Range 0-5. For results below, positive change represents improvement/ better performance.
Secondary	Function, Activities of Daily Living (ADL)	12 months	ADL 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.
Secondary	Behavior	12 months	Neuropsychiatric Inventory, change from baseline at 12 months. Range 0-120. For results below, positive change represents improvement/ better performance.
Secondary	Cognitive (Neuropsychological)	12 months	Global 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.
Secondary	ADAS-cog	6 months	Change from baseline at 6 months, compared between groups. Error score range 0-70. For results below, positive change represents improvement/ better performance.
Secondary	Clinical Dementia Rating, Sum of Boxes	6 months	Change from baseline at 6 months, compared between groups. Range 0-5. For results below, positive change represents improvement/ better performance.
Secondary	Function, Activities of Daily Living	6 months	Change from baseline at 6 months, compared between groups. Range 0-78. For results below, positive change represents improvement/ better performance.
Secondary	Behavior	6 months	Neuropsychiatric Inventory, change from baseline at 6 months, compared between groups. Range 0-120. For results below, positive change represents improvement/ better performance.
Secondary	Cognition (Neuropsychological)	6 months	Global 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.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-cog)	12 months	Intent-to-treat	units on a scale	MEAN
SECONDARY	Global Rating, Clinical Dementia Rating (CDR) Sum of Boxes	12 months		units on a scale	MEAN
SECONDARY	Function, Activities of Daily Living (ADL)	12 months		units on a scale	MEAN
SECONDARY	Behavior	12 months		units on a scale	MEAN
SECONDARY	Cognitive (Neuropsychological)	12 months		units on a scale	MEAN
SECONDARY	ADAS-cog	6 months		units on a scale	MEAN
SECONDARY	Clinical Dementia Rating, Sum of Boxes	6 months		units on a scale	MEAN
SECONDARY	Function, Activities of Daily Living	6 months		units on a scale	MEAN
SECONDARY	Behavior	6 months		units on a scale	MEAN
SECONDARY	Cognition (Neuropsychological)	6 months		units on a scale	MEAN

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-cog)	Raloxifene	-3.2	Standard Deviation 5.8	units on a scale
Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-cog)	Placebo	-3.5	Standard Deviation 8.0	units on a scale
Global Rating, Clinical Dementia Rating (CDR) Sum of Boxes	Raloxifene	-2.6	Standard Deviation 1.8	units on a scale
Global Rating, Clinical Dementia Rating (CDR) Sum of Boxes	Placebo	-2.0	Standard Deviation 3.2	units on a scale
Function, Activities of Daily Living (ADL)	Raloxifene	-9.1	Standard Deviation 9.4	units on a scale
Function, Activities of Daily Living (ADL)	Placebo	-4.5	Standard Deviation 9.5	units on a scale
Behavior	Raloxifene	-2.3	Standard Deviation 7.8	units on a scale
Behavior	Placebo	-2.5	Standard Deviation 6.3	units on a scale
Cognitive (Neuropsychological)	Raloxifene	-0.6	Standard Deviation 1.8	units on a scale
Cognitive (Neuropsychological)	Placebo	-1.1	Standard Deviation 1.4	units on a scale

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Raloxifene	21
Overall Study	STARTED	Placebo	21
Overall Study	COMPLETED	Raloxifene	19
Overall Study	COMPLETED	Placebo	20
Overall Study	NOT COMPLETED	Raloxifene	2
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events38

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	urinary tract infection	Renal and urinary disorders	Raloxifene	3	21	5
other	urinary tract infection	Renal and urinary disorders	Placebo	1	21	1
other	cold symptoms	General disorders	Raloxifene	3	21	3
other	cold symptoms	General disorders	Placebo	2	21	2
other	decreased appetite	General disorders	Raloxifene	3	21	3
other	decreased appetite	General disorders	Placebo	0	21	0
other	back pain	Musculoskeletal and connective tissue disorders	Raloxifene	2	21	2
other	back pain	Musculoskeletal and connective tissue disorders	Placebo	0	21	0
other	arm or shoulder pain	Musculoskeletal and connective tissue disorders	Raloxifene	2	21	2
other	arm or shoulder pain	Musculoskeletal and connective tissue disorders	Placebo	0	21	0

1 to 10 of 38Source ClinicalTrials.gov

See all 38 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Raloxifene
Total, all-cause mortality	Placebo
Total, other adverse events	Raloxifene	16	21
Total, other adverse events	Placebo	13	21
Total, serious adverse events	Raloxifene	2	21
Total, serious adverse events	Placebo	1	21

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Raloxifene vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00368459

GET https://conductscience.org/api/trials/v1/NCT00368459/events?page=2

API reference For AI assistants