HARALD: Hormone Replacement Trial Against ALzheimers' Disease
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
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Postmenopausal women who start oral hormonal treatment
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Postmenopausal women who start transdermal hormonal treatment
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Postmenopausal women who start oral hormonal treatment and had a hysterectomy in their medical history
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Postmenopausal women who start transdermal hormonal treatment and had a hysterectomy in their medical history
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Postmenopausal women who start oral hormonal treatment and have an intra-uterine device
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Postmenopausal women who start transdermal hormonal treatment and have an intra-uterine device
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Postmenopausal women with breast cancer taking selective oestrogen receptor modulators
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Postmenopausal women with breast cancer taking aromatase inhibitors
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Postmenopausal women with breast cancer taking duavive
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Postmenopausal women with no breast cancer and do not start with hormonal therapy
The questionnaires that needs to be completed are:
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Mini Mental State Examination (only at the first visit)
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Targeting Aetiology of Nocturia Guides Outcomes Short Form (TANGO-SF) (visit 1 and 2)
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International Consultation of Incontinence Modular Questionnaire (ICIQ) (visit 1 and 2)
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Perceived stress scale (Cohen) (visit 1 and 2)
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Pittsburgh sleep quality
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: oral hormonal therapy 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. |
Procedure: blood take
Blood is taken to analyse degratdation products of the metabolism of amyloid
|
| Other: transdermal hormonal therapy 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. |
Procedure: blood take
Blood is taken to analyse degratdation products of the metabolism of amyloid
|
| Other: oral hormonal therapy + hysterectomy 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. |
Procedure: blood take
Blood is taken to analyse degratdation products of the metabolism of amyloid
|
| Other: transdermal hormonal therapy + hysterectomy 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. |
Procedure: blood take
Blood is taken to analyse degratdation products of the metabolism of amyloid
|
| Other: oral hormonal therapy + IUD 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. |
Procedure: blood take
Blood is taken to analyse degratdation products of the metabolism of amyloid
|
| Other: transdermal hormonal therapy + IUD 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. |
Procedure: blood take
Blood is taken to analyse degratdation products of the metabolism of amyloid
|
| Other: selective oestrogenreceptor modulators 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. |
Procedure: blood take
Blood is taken to analyse degratdation products of the metabolism of amyloid
|
| Other: aromatase inhibitors 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. |
Procedure: blood take
Blood is taken to analyse degratdation products of the metabolism of amyloid
|
| Other: Duavive 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. |
Procedure: blood take
Blood is taken to analyse degratdation products of the metabolism of amyloid
|
| Other: Control 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. |
Procedure: blood take
Blood is taken to analyse degratdation products of the metabolism of amyloid
|
Outcome Measures
Primary Outcome Measures
- Degradation products of the Amyloid metabolism in blood [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
- Degradation products of the Amyloid metabolism in blood [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
- Degradation products of the Amyloid metabolism in blood [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
- Degradation products of the Amyloid metabolism in blood [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
- Degradation products of the Amyloid metabolism in blood [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
- Degradation products of the Amyloid metabolism in blood [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
- APOE-genotyping in blood [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
- identify BACE1 in blood [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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postmenopausal women
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40 - 65 years
Exclusion Criteria:
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Longer than 10 years in menopause
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thyroid dysfunction
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hypertension
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medical history of psychiatric comorbidity
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Alcohol and/or drug abuse
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medical history of neurologic symptoms with cognitive symptoms
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ghent university hospital | Ghent | Belgium | 9000 |
Sponsors and Collaborators
- University Hospital, Ghent
Investigators
- Principal Investigator: Herman Depypere, MD, University Hospital, Ghent
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EC/2018/0315