Hormone Replacement Trial Against ALzheimers' Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: blood take.
- Who it may be relevant to
- Registry conditions: Postmenopausal Symptoms, Alzheimer Disease. Basic parameters: 40 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Procedure blood take
Blood is taken to analyse degradation products of the metabolism of amyloid
Primary outcome measures
- Degradation products of the Amyloid metabolism in blood [Time frame: 2 years after the first patient was included, the first batch of samples will be analysed.]
- Degradation products of the Amyloid metabolism in blood [Time frame: 2 years after the first patient was included, the first batch of samples will be analysed.]
- Degradation products of the Amyloid metabolism in blood [Time frame: 2 years after the first patient was included, the first batch of samples will be analysed.]
- Degradation products of the Amyloid metabolism in blood [Time frame: 2 years after the first patient was included, the first batch of samples will be analysed.]
- Degradation products of the Amyloid metabolism in blood [Time frame: 2 years after the first patient was included, the first batch of samples will be analysed.]
- Degradation products of the Amyloid metabolism in blood [Time frame: 2 years after the first patient was included, the first batch of samples will be analysed.]
- APOE-genotyping in blood [Time frame: 2 years after the first patient was included, the first batch of samples will be analysed.]
- identify BACE1 in blood [Time frame: 2 years after the first patient was included, the first batch of samples will be analysed.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Belgium · 1 center
- Ghent university hospital — Ghent
Identifiers
NCT: NCT04312399 · EC/2018/0315