Clinical Trials in Belgium / NCT04312399
Recruiting
Not applicable
Hormone Replacement Trial Against ALzheimers' Disease
NCT04312399 · tracked via the Priya Life Science Belgium tracker
Condition(s) studied
Postmenopausal SymptomsAlzheimer Disease
Investigational drug(s) / intervention(s)
blood take
blood take: Blood is taken to analyse degradation products of the metabolism of amyloid
Study 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.
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
Primary outcome measure(s)
- 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: Plasma total-tau - 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: Nurofilament light chain - 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: Abeta1-40 - 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: Abeta1-42 - 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: YKL-40 - 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 - 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 - 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Ghent university hospital | Ghent | Belgium | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04312399 on ClinicalTrials.gov ↗ ← All trials in Belgium