Hormone Replacement Trial Against ALzheimers' Disease

Not Applicable

Recruiting

• Conditions: Alzheimer Disease; Postmenopausal Symptoms

• Registration Number: NCT04312399
• Lead Sponsor: University Hospital, Ghent

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2018-04-17
• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-03-17
• Study First Posted: 2020-03-18
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-27
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

• postmenopausal women
• 40 - 65 years

Exclusion Criteria

• Longer than 10 years in menopause
• thyroid dysfunction
• hypertension
• medical history of psychiatric comorbidity
• Alcohol and/or drug abuse
• medical history of neurologic symptoms with cognitive symptoms

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Degradation products of the Amyloid metabolism in blood	2 years after the first patient was included, the first batch of samples will be analysed.	The influence of hormone treatment (menopause) and anti-hormone treatment (breastcancer) on the amyloid metabolism and the development of Alzheimer will be evaluated. Different laboratory analysis will be performed to evaluate the degradation products of the metabolism of amyloid in blood. Different parts of the degradation products will be analysed namely: Neurogranin
identify BACE1 in blood	2 years after the first patient was included, the first batch of samples will be analysed.	The influence of hormone treatment (menopause) and anti-hormone treatment (breastcancer) on the amyloid metabolism and the development of Alzheimer will be evaluated. BACE1 will also be identified in the blood.
APOE-genotyping in blood	2 years after the first patient was included, the first batch of samples will be analysed.	The influence of hormone treatment (menopause) and anti-hormone treatment (breastcancer) on the amyloid metabolism and the development of Alzheimer will be evaluated. APOE-genotyping will be performed

Trial Locations

Locations (1)

Ghent university hospital; 🇧🇪 Ghent, Belgium