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

Effect of hormone therapy combined with donepezil in women with mild cognitive impairment

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0002516

Enrollment

162

Registered

2017-10-31

Start date

2008-01-15

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : 1) hormone therapy : 0.1&#37

estradiol gel (2 gm/d percutaneously) + micronized progesterone (100 mg/d, orally) for 2 years 2) placebo

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
modified ADAS-cog	—

Secondary

Measure	Time frame
NPI (neuropsychiatric inventory);IADL (Bayer Instrumental Activities of Daily Living);MMSE (Mini-Mental State Examination);MoCA (Montreal Cognitive Assessment);GQOL (Geriatric Quality of Life)	—

Countries

Korea, Republic of

Contacts

Public ContactByung-Koo Yoon

Samsung Medical Center

bkyoon@skku.edu+82-2-3410-3519

Outcome results