Phase 2
Completed N=42
Raloxifene for Women With Alzheimer's Disease
Source: ClinicalTrials.gov NCT00368459 ↗Enrolled (actual)
42
Serious AEs
7.1%
Results posted
Apr 2015
Primary outcomePrimary: Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-cog) — -3.2; -3.5 units on a scale — p=>0.1
Summary
This is a multisite pilot randomized trial of raloxifene or placebo for the treatment of women with Alzheimer's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-cog) |
-3.2; -3.5 | >0.1 |
| SECONDARY Global Rating, Clinical Dementia Rating (CDR) Sum of Boxes |
-2.6; -2.0 | >0.1 |
| SECONDARY Function, Activities of Daily Living (ADL) |
-9.1; -4.5 | >0.1 |
| SECONDARY Behavior |
-0.7; -2.1 | >0.1 |
| SECONDARY Cognitive (Neuropsychological) |
-0.6; -1.1 | >0.1 |
| SECONDARY ADAS-cog |
-0.7; -1.8 | >0.1 |
| SECONDARY Clinical Dementia Rating, Sum of Boxes |
-0.8; -1.0 | >0.1 |
| SECONDARY Function, Activities of Daily Living |
-6.9; -0.3 | <0.01 sig |
| SECONDARY Behavior |
-0.7; -2.1 | >0.1 |
| SECONDARY Cognition (Neuropsychological) |
-0.5; -0.6 | >0.1 |
Eligibility Criteria
Inclusion Criteria
- Female
- Post menopausal
- Age at least 60 years
- Eight or more years of education with a history of premorbid literacy
- By history, fluent speaker of English
- Dementia (DSM-IV-derived criteria) present for at least six months beginning at age 60 or older
- Mild or moderate dementia, defined by Mini-Mental State examination (MMSE) score between 12 and 26, inclusive
- National Institute of Neurological and Communicative Disease and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable Alzheimer's disease (AD) based on results of a neurologist's evaluation and laboratory tests
- Neurological history and examination within normal limits for age, except for changes consistent with AD or age
- Modified Ischemia Scale score of 4 or less
- Good physical health established by medical history, physical exam, and baseline laboratory tests
- Blood pressure < 180/100 at time of entry
- No history of, or examination evidence for, current insulin-dependent diabetes, stroke thought to impair cognition (e.g., cortical or thalamic infarct), or other focal brain lesion or neurological disorder likely to affect cognition, or other serious medical illness likely to limit participant's ability to complete study protocol
- No history of pulmonary embolism, deep vein thrombosis, or retinal vein occlusion
- No Diagnostic and Statistical Manual (DSM) IV criteria for Major Depressive Episode or other Axis I psychiatric disorder, other than AD, within the past year
- Effective dose of an FDA-approved cholinesterase inhibitor for at least 6 months prior to randomization (usually donepezil 5 or 10 mg/d, rivastigmine 6 to 12 mg/d, or galantamine 16 to 24 mg/d); stable effective dose for at least 2 months prior to randomization
- No psychotropic medication within 4 weeks of study entry or stable dose (for at least 4 weeks month) of psychotropic medications
- No experimental mediation for the treatment of cognitive impairment associated with dementia within 2 months of study entry
- No raloxifene within 6 months of study entry
- No systemic estrogen, progestin, testosterone, related gonadal hormone therapy within 2 months of study entry
- No other known contraindication to raloxifene or donepezil
- A primary caregiver who knows the participant well and who is able to accompany her for regular assessments during the course of the study
- Assent or consent of participant plus informed consent from participant's next of kin or legally authorized representative
Exclusion Criteria
- Failure to meet inclusion criteria
Data sourced from ClinicalTrials.gov (NCT00368459). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.