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NCT Number: NCT04312399

Hormone Replacement Trial Against ALzheimers' Disease

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.

Recruiting

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Key information

Conditions

Postmenopausal Symptoms Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ghent university hospital

Ghent, 9000, Belgium

Location status: Recruiting

Location contact

Eline Meireson, Msc

CONTACT

[email protected]

0032 9 332 78 17

Herman Depypere, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood take

Procedure

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

Primary outcomes

  1. 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.

    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. 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.

    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

  3. 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.

    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

  4. 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.

    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

  5. 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.

    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

  6. 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.

    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

  7. APOE-genotyping in blood

    Time frame: 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

  8. identify BACE1 in blood

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eline Meireson, Msc

CONTACT

[email protected]

0032 9 332 78 17

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Acronym: HARALD

Important dates

Study start
2018
Primary completion
2027
Study completion
2028
First posted
Mar 18, 2020
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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