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Hormone Replacement Trial Against ALzheimers' Disease

Hormone Replacement Trial Against ALzheimers' Disease

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04312399
Acronym
HARALD
Enrollment
600
Registered
2020-03-18
Start date
2018-04-17
Completion date
2028-12-31
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Postmenopausal Symptoms

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.

Interventions

PROCEDUREblood take

Blood is taken to analyse degradation products of the metabolism of amyloid

Sponsors

University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

10 study groups: 9 groups who start with hormonal treatment and 1 control group who doesn't start with hormonal treatment

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Degradation products of the Amyloid metabolism in blood2 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
APOE-genotyping in blood2 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 blood2 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.

Countries

Belgium

Contacts

Primary ContactEline Meireson, Msc
eline.meireson@uzgent.be0032 9 332 78 17

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026