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Hormone Replacement Trial Against ALzheimers' Disease (HARALD)

Primary Purpose

Postmenopausal Symptoms, Alzheimer Disease

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
blood take
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Postmenopausal Symptoms

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Ghent university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Other

Other

Other

Other

Other

Other

Other

Other

Other

Other

Arm Label

oral hormonal therapy

transdermal hormonal therapy

oral hormonal therapy + hysterectomy

transdermal hormonal therapy + hysterectomy

oral hormonal therapy + IUD

transdermal hormonal therapy + IUD

selective oestrogenreceptor modulators

aromatase inhibitors

Duavive

Control

Arm Description

Postmenopausal women who start with oral hormonal therapy (Progesteron + uterogestan) according to standard of care practice. Before the start of the treatment blood will be taken and 6 months after the start of the therapy blood will be taken for analysis. At the 2 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.

Postmenopausal women who start with transdermal hormonal (Oestrogel + uterogestan) therapy according to standard of care practice. Before the start of the treatment blood will be taken and 6 months after the start of the therapy blood will be taken for analysis. At the 2 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.

Postmenopausal women who start with oral hormonal therapy (progesteron) according to standard of care practice and had a hysterectomy in the past. Before the start of the treatment blood will be taken and 6 months after the start of the therapy blood will be taken for analysis. At the 2 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.

Postmenopausal women who start with transdermal hormonal therapy (Oestrogel ) according to standard of care practice and had a hysterectomy in the past. Before the start of the treatment blood will be taken and 6 months after the start of the therapy blood will be taken for analysis. At the 2 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.

Postmenopausal women who start with oral hormonal therapy (Progynova) according to standard of care practice and have already an intra-uterine device. Before the start of the treatment blood will be taken and 6 months after the start of the therapy blood will be taken for analysis. At the 2 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.

Postmenopausal women who start with transdermal hormonal therapy (Oestrogel ) according to standard of care practice and have an intra-uterine device. Before the start of the treatment blood will be taken and 6 months after the start of the therapy blood will be taken for analysis. At the 2 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.

Postmenopausal women who start with hormonal therapy according to standard of care practice and take selective oestrogenreceptor modulators (Nolvadex) because of their cancer in their medical history. Before the start of the treatment blood will be taken and 6 months after the start of the therapy blood will be taken for analysis. At the 2 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.

Postmenopausal women who start with hormonal therapy according to standard of care practice and who taken aromatase inhibitors (Femara) because of their cancer in their medical history. Before the start of the treatment blood will be taken and 6 months after the start of the therapy blood will be taken for analysis. At the 2 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.

Postmenopausal women who start with hormonal therapy according to standard of care practice and who take duavive because of their cancer in their medical history. Before the start of the treatment blood will be taken and 6 months after the start of the therapy blood will be taken for analysis. At the 2 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.

Postmenopausal women who don't start with hormonal therapy according to standard of care practice. At the first study visit blood will be taken and 6 months after the start of the therapy blood will be taken for analysis. At the 2 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.

Outcomes

Primary Outcome Measures

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
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
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
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
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: YKL-40
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: Neurogranin
APOE-genotyping 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. APOE-genotyping will be performed
identify BACE1 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. BACE1 will also be identified in the blood.

Secondary Outcome Measures

Full Information

First Posted
January 8, 2020
Last Updated
December 8, 2022
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT04312399
Brief Title
Hormone Replacement Trial Against ALzheimers' Disease
Acronym
HARALD
Official Title
Hormone Replacement Trial Against ALzheimers' Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The influence of postmenopausal hormone treatment on dementia is not clear. Recently an overview was published. Dysfunctions in the metabolism of amyloid in the disease of Alzheimer result in an elevated presence of degradation products in cerebrospinal fluid. There are tests developed to detect those degradation products in blood. The degradation products in blood will be analysed during the trial, to get better insight in menopause and the start of hormonal therapy. The participants will be asked to come 2 times to the hospital. At every study visit, blood will be taken and questionnaires will be completed. The first study visit will take place before the start of the hormonal treatment, the second visit will take place 6 months after the start of the hormonal treatment. There will be 30 patients included per study group. There are 10 groups in total: Postmenopausal women who start oral hormonal treatment Postmenopausal women who start transdermal hormonal treatment Postmenopausal women who start oral hormonal treatment and had a hysterectomy in their medical history Postmenopausal women who start transdermal hormonal treatment and had a hysterectomy in their medical history Postmenopausal women who start oral hormonal treatment and have an intra-uterine device Postmenopausal women who start transdermal hormonal treatment and have an intra-uterine device Postmenopausal women with breast cancer taking selective oestrogen receptor modulators Postmenopausal women with breast cancer taking aromatase inhibitors Postmenopausal women with breast cancer taking duavive Postmenopausal women with no breast cancer and do not start with hormonal therapy The questionnaires that needs to be completed are: Mini Mental State Examination (only at the first visit) Targeting Aetiology of Nocturia Guides Outcomes Short Form (TANGO-SF) (visit 1 and 2) International Consultation of Incontinence Modular Questionnaire (ICIQ) (visit 1 and 2) Perceived stress scale (Cohen) (visit 1 and 2) Pittsburgh sleep quality

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Symptoms, Alzheimer Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
10 study groups: 9 groups who start with hormonal treatment and 1 control group who doesn't start with hormonal treatment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
oral hormonal therapy
Arm Type
Other
Arm Description
Postmenopausal women who start with oral hormonal therapy (Progesteron + uterogestan) according to standard of care practice. Before the start of the treatment blood will be taken and 6 months after the start of the therapy blood will be taken for analysis. At the 2 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.
Arm Title
transdermal hormonal therapy
Arm Type
Other
Arm Description
Postmenopausal women who start with transdermal hormonal (Oestrogel + uterogestan) therapy according to standard of care practice. Before the start of the treatment blood will be taken and 6 months after the start of the therapy blood will be taken for analysis. At the 2 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.
Arm Title
oral hormonal therapy + hysterectomy
Arm Type
Other
Arm Description
Postmenopausal women who start with oral hormonal therapy (progesteron) according to standard of care practice and had a hysterectomy in the past. Before the start of the treatment blood will be taken and 6 months after the start of the therapy blood will be taken for analysis. At the 2 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.
Arm Title
transdermal hormonal therapy + hysterectomy
Arm Type
Other
Arm Description
Postmenopausal women who start with transdermal hormonal therapy (Oestrogel ) according to standard of care practice and had a hysterectomy in the past. Before the start of the treatment blood will be taken and 6 months after the start of the therapy blood will be taken for analysis. At the 2 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.
Arm Title
oral hormonal therapy + IUD
Arm Type
Other
Arm Description
Postmenopausal women who start with oral hormonal therapy (Progynova) according to standard of care practice and have already an intra-uterine device. Before the start of the treatment blood will be taken and 6 months after the start of the therapy blood will be taken for analysis. At the 2 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.
Arm Title
transdermal hormonal therapy + IUD
Arm Type
Other
Arm Description
Postmenopausal women who start with transdermal hormonal therapy (Oestrogel ) according to standard of care practice and have an intra-uterine device. Before the start of the treatment blood will be taken and 6 months after the start of the therapy blood will be taken for analysis. At the 2 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.
Arm Title
selective oestrogenreceptor modulators
Arm Type
Other
Arm Description
Postmenopausal women who start with hormonal therapy according to standard of care practice and take selective oestrogenreceptor modulators (Nolvadex) because of their cancer in their medical history. Before the start of the treatment blood will be taken and 6 months after the start of the therapy blood will be taken for analysis. At the 2 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.
Arm Title
aromatase inhibitors
Arm Type
Other
Arm Description
Postmenopausal women who start with hormonal therapy according to standard of care practice and who taken aromatase inhibitors (Femara) because of their cancer in their medical history. Before the start of the treatment blood will be taken and 6 months after the start of the therapy blood will be taken for analysis. At the 2 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.
Arm Title
Duavive
Arm Type
Other
Arm Description
Postmenopausal women who start with hormonal therapy according to standard of care practice and who take duavive because of their cancer in their medical history. Before the start of the treatment blood will be taken and 6 months after the start of the therapy blood will be taken for analysis. At the 2 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.
Arm Title
Control
Arm Type
Other
Arm Description
Postmenopausal women who don't start with hormonal therapy according to standard of care practice. At the first study visit blood will be taken and 6 months after the start of the therapy blood will be taken for analysis. At the 2 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.
Intervention Type
Procedure
Intervention Name(s)
blood take
Intervention Description
Blood is taken to analyse degratdation products of the metabolism of amyloid
Primary Outcome Measure Information:
Title
Degradation products of the Amyloid metabolism in blood
Description
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.
Title
Degradation products of the Amyloid metabolism in blood
Description
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.
Title
Degradation products of the Amyloid metabolism in blood
Description
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.
Title
Degradation products of the Amyloid metabolism in blood
Description
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.
Title
Degradation products of the Amyloid metabolism in blood
Description
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
Time Frame
2 years after the first patient was included, the first batch of samples will be analysed.
Title
Degradation products of the Amyloid metabolism in blood
Description
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
Time Frame
2 years after the first patient was included, the first batch of samples will be analysed.
Title
APOE-genotyping in blood
Description
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
Time Frame
2 years after the first patient was included, the first batch of samples will be analysed.
Title
identify BACE1 in blood
Description
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.
Time Frame
2 years after the first patient was included, the first batch of samples will be analysed.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eline Meireson, Msc
Phone
0032 9 332 78 17
Email
eline.meireson@uzgent.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herman Depypere, MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent university hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eline Meireson, Msc
Phone
0032 9 332 78 17
Email
eline.meireson@uzgent.be
First Name & Middle Initial & Last Name & Degree
Herman Depypere, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Hormone Replacement Trial Against ALzheimers' Disease

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