NCT00066157

Brief Summary

This is a 15-month study to determine the effectiveness of hormone replacement therapy in improving memory and the ability to live independently in postmenopausal women with Alzheimer's disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2 alzheimer-disease

Timeline
Completed

Started Sep 2001

Longer than P75 for phase_2 alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2003

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

August 23, 2018

Status Verified

August 1, 2018

Enrollment Period

6.3 years

First QC Date

August 4, 2003

Last Update Submit

August 22, 2018

Conditions

Alzheimer Disease

Keywords

Alzheimer diseaseHormone replacement therapyPostmenopausal women

Outcome Measures

Primary Outcomes (1)

  • Cognition: delayed recall on Buschke Selective Reminding Test; Stroop Interference condition--completion time and errors; Clinician-rated Interview Based Impression of Change

    Baseline and 1, 3, 6, 12, and 15 months

Secondary Outcomes (2)

  • Skills of Independent Living: Physical functioning Performance (PFP)

    Baseline and 1, 3, 6, 12, and 15 months

  • Bioassays (Estradiol, estrone, medroxyprogesterone, FSH, influence of ApoE genotype in responsivity to estrogen)

    Baseline and 1, 3, 6, 12, and 15 months

Study Arms (4)

1

EXPERIMENTAL

estradiol patch and medroxyprogesterone

Drug: Transdermal estradiolDrug: Medroxyprogesterone

2

ACTIVE COMPARATOR

estradiol patch and placebo pill

Drug: Transdermal estradiolDrug: Placebo

3

ACTIVE COMPARATOR

placebo patch and medroxyprogesterone

Drug: MedroxyprogesteroneDrug: Placebo Patch

4

PLACEBO COMPARATOR

placebo patch and placebo pill

Drug: Placebo PatchDrug: Placebo

Interventions

Transdermal estradiolDRUG

50 micrograms (low-dose) or 100 micrograms (high-dose) transdermal 17-ß-estradiol patch, changed every 3 days, for 12 months

Also known as: 17 (beta) estradiol transdermal patch, Estrogen replacement therapy
12
MedroxyprogesteroneDRUG

2.5mg tablet daily for 12 months

Also known as: progesterone
13
Placebo PatchDRUG

Transdermal placebo patch, changed every 3 days, for 12 months

34
PlaceboDRUG

Placebo tablet daily for 12 months

24

Eligibility Criteria

Age55 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women with Alzheimer's disease and without other dementias (diagnosed by study staff or from an outside clinic)
  • Mini Mental State Examination score greater than 15/30

You may not qualify if:

  • History of cancer of reproductive tissues
  • History of deep vein thrombosis or blot clots
  • Diabetes
  • Heart disease or stroke
  • Liver problems including hepatitis
  • Severe vision or hearing problems
  • Tobacco use
  • Lack of an adequate caregiver
  • inability to perform psychometric testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Memory Research Program

Madison, Wisconsin, 53705, United States

Location

Related Publications (3)

  • Cholerton B, Gleason CE, Baker LD, Asthana S. Estrogen and Alzheimer's disease: the story so far. Drugs Aging. 2002;19(6):405-27. doi: 10.2165/00002512-200219060-00002.

    PMID: 12149049BACKGROUND

  • Asthana S, Baker LD, Craft S, Stanczyk FZ, Veith RC, Raskind MA, Plymate SR. High-dose estradiol improves cognition for women with AD: results of a randomized study. Neurology. 2001 Aug 28;57(4):605-12. doi: 10.1212/wnl.57.4.605.

    PMID: 11524467BACKGROUND

  • Asthana S, Craft S, Baker LD, Raskind MA, Birnbaum RS, Lofgreen CP, Veith RC, Plymate SR. Cognitive and neuroendocrine response to transdermal estrogen in postmenopausal women with Alzheimer's disease: results of a placebo-controlled, double-blind, pilot study. Psychoneuroendocrinology. 1999 Aug;24(6):657-77. doi: 10.1016/s0306-4530(99)00020-7.

    PMID: 10399774BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Estrogen Replacement TherapyMedroxyprogesteroneProgesterone

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Hormone Replacement TherapyDrug TherapyTherapeuticsHydroxyprogesteronesPregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Study Officials

  • Sanjay Asthana, MD

    University of Wisconsin - Madison, William S. Middleton VA Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2003

First Posted

August 5, 2003

Study Start

September 1, 2001

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

August 23, 2018

Record last verified: 2018-08

Locations

US(1)