Hormone Replacement Trial Against ALzheimers' Disease — HARALD  

Alzheimer Disease Clinical Trial

Official title: Hormone Replacement Trial Against ALzheimers' Disease

Status Active, not recruiting

Clinical Trial Summary

The influence of postmenopausal hormone treatment on dementia is not clear. Dysfunctions in the metabolism of amyloid in the disease of Alzheimer result in an elevated presence of degradation products in cerebrospinal fluid.

The degradation products in blood will be analysed during the trial, to get better insight in menopause and the start of hormonal therapy.

Postmenopausal women with and without history of breast cancer will be recruited for the trial.

Clinical Trial Description

The influence of postmenopausal hormone treatment on dementia is not clear. Recently an overview was published.

Dysfunctions in the metabolism of amyloid in the disease of Alzheimer result in an elevated presence of degradation products in cerebrospinal fluid. There are tests developed to detect those degradation products in blood.

The degradation products in blood will be analysed during the trial, to get better insight in menopause and the start of hormonal therapy. The participants will be asked to come 2 times to the hospital. At every study visit, blood will be taken and questionnaires will be completed. The first study visit will take place before the start of the hormonal treatment, the second visit will take place 6 months after the start of the hormonal treatment.

There will be 30 patients included per study group. There are 10 groups in total:

1. Postmenopausal women who start oral hormonal treatment

2. Postmenopausal women who start transdermal hormonal treatment

3. Postmenopausal women who start oral hormonal treatment and had a hysterectomy in their medical history

4. Postmenopausal women who start transdermal hormonal treatment and had a hysterectomy in their medical history

5. Postmenopausal women who start oral hormonal treatment and have an intra-uterine device

6. Postmenopausal women who start transdermal hormonal treatment and have an intra-uterine device

7. Postmenopausal women with breast cancer taking selective oestrogen receptor modulators

8. Postmenopausal women with breast cancer taking aromatase inhibitors

9. Postmenopausal women with breast cancer taking duavive

10. Postmenopausal women with no breast cancer and do not start with hormonal therapy

The questionnaires that needs to be completed are:

1. Mini Mental State Examination (only at the first visit)

2. Targeting Aetiology of Nocturia Guides Outcomes Short Form (TANGO-SF) (visit 1 and 2)

3. International Consultation of Incontinence Modular Questionnaire (ICIQ) (visit 1 and 2)

4. Perceived stress scale (Cohen) (visit 1 and 2)

5. Pittsburgh sleep quality ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Postmenopausal Symptoms

• NCT number: NCT04312399
• Study type: Interventional
• Source: University Hospital, Ghent
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 17, 2018
• Completion date: December 31, 2024