Effect of menopausal hormone therapy combined with donepezil, used for the treatment of Alzheimer's disease, in women with mild cognitive impairment

Not Applicable

Recruiting

• Conditions: Diseases of the nervous system

• Registration Number: KCT0002516
• Lead Sponsor: Samsung Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 162

Inclusion Criteria

Age: 50-85 years old
- Postmenopausal women: natural or surgical
- A diagnosis of mild cognitive impairment (amnestic subtype) according to Peterson’s criteria
- MMSE score > (normal average – 1x standard deviation)
- In good physical ability which allows the patient to visit outpatient clinic with some assistance

Exclusion Criteria

- An advanced, severe, progressive, or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient at special risk
- Any medical or neurological condition that might cause dementia or cognitive impairment (e.g., abnormal thyroid function tests, vitamine B12 or folate deficiency, posttraumatic conditions, Huntington’s disease, Parkinson’s disease, multiple sclerosis, cerebral palsy, encephalitis, encephalomeningitis, syphilis)
- A current DSM-IV diagnosis of major depression, unless successfully treated with a stable dose of an antidepressant without anticholinergic properties for least 4 weeks
- Severe liver disease or impaired renal function severe enough to need a dialysis
- Past history of hospital admission due to psychosis or affective disorders for the past five years.
- Past history within the past five years of alcohol or other drug intoxication that had to be treated
- Past history of prolonged loss of consciousness more than one hour or serious head injury that needed to be admitted for treatment.
- A disability that may prevent the patient from completing all study requirements (e.g., blindness, deafness, sever language difficulty)
- Induced menopause with anti-cancer chemotherapy or radiation therapy
- Breast cancer
- Active thrombophlebitis (deep vein thrombosis, pulmonary thromboembolism)
- Undiagnosed vaginal bleeding
- Acute liver disease (GOT/GPT: above twice the upper limit of normal range)
- Allergy against the trial medicine
- Current or recent user (< 3 months) of HT
- Current or recent user (< 3 months) of donepezil

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
modified ADAS-cog

Secondary Outcome Measures

Name	Time	Method
PI (neuropsychiatric inventory);IADL (Bayer Instrumental Activities of Daily Living);MMSE (Mini-Mental State Examination);MoCA (Montreal Cognitive Assessment);GQOL (Geriatric Quality of Life)