Hormone Replacement Trial Against ALzheimers' Disease

Alzheimer Disease Clinical Trial

— HARALD  

Official title:

Hormone Replacement Trial Against ALzheimers' Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04312399
• Other study ID #: EC/2018/0315
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 17, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 421
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Postmenopausal Symptoms

Intervention

Procedure:
• blood take
Blood is taken to analyse degratdation products of the metabolism of amyloid

Locations

Country	Name	City	State
Belgium	Ghent university hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degradation products of the Amyloid metabolism in blood	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: Plasma total-tau	2 years after the first patient was included, the first batch of samples will be analysed.
Primary	Degradation products of the Amyloid metabolism in blood	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: Nurofilament light chain	2 years after the first patient was included, the first batch of samples will be analysed.
Primary	Degradation products of the Amyloid metabolism in blood	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: Abeta1-40	2 years after the first patient was included, the first batch of samples will be analysed.
Primary	Degradation products of the Amyloid metabolism in blood	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: Abeta1-42	2 years after the first patient was included, the first batch of samples will be analysed.
Primary	Degradation products of the Amyloid metabolism in blood	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: YKL-40	2 years after the first patient was included, the first batch of samples will be analysed.
Primary	Degradation products of the Amyloid metabolism in blood	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	2 years after the first patient was included, the first batch of samples will be analysed.
Primary	APOE-genotyping in blood	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	2 years after the first patient was included, the first batch of samples will be analysed.
Primary	identify BACE1 in blood	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.	2 years after the first patient was included, the first batch of samples will be analysed.