Hormone Replacement Trial Against ALzheimers' Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-65
SponsorUniversity Hospital, Ghent
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
postmenopausal women
40 - 65 years
Disqualifiers
Longer than 10 years in menopause
thyroid dysfunction
hypertension
medical history of psychiatric comorbidity
Trial design
Design model
Parallel
Treatments tested in this trial
blood take
Procedure/SurgeryBlood is taken to analyse degradation products of the metabolism of amyloid
Treatment groups
600 Participants
are divided into 10 treatment groups10
Treatment groupsSee each treatment group below.
Group A: oral hormonal therapyOther 1 intervention
Group B: transdermal hormonal therapyOther 1 intervention
Group C: oral hormonal therapy + hysterectomyOther 1 intervention
Group D: transdermal hormonal therapy + hysterectomyOther 1 intervention
Group E: oral hormonal therapy + IUDOther 1 intervention
Group F: transdermal hormonal therapy + IUDOther 1 intervention
Group G: selective oestrogenreceptor modulatorsOther 1 intervention
Group H: aromatase inhibitorsOther 1 intervention
Group I: DuaviveOther 1 intervention
Group J: ControlOther 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
2 years after the first patient was included, the first batch of samples will be analysed.2
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
Time frame
2 years after the first patient was included, the first batch of samples will be analysed.3
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
Time frame
2 years after the first patient was included, the first batch of samples will be analysed.4
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
Time frame
2 years after the first patient was included, the first batch of samples will be analysed.Sponsors and contacts
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Source ClinicalTrials.gov