Hormone Replacement Trial Against ALzheimers' Disease
Клучни зборови
Апстракт
Опис
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:
1. Postmenopausal women who start oral hormonal treatment
2. Postmenopausal women who start transdermal hormonal treatment
3. Postmenopausal women who start oral hormonal treatment and had a hysterectomy in their medical history
4. Postmenopausal women who start transdermal hormonal treatment and had a hysterectomy in their medical history
5. Postmenopausal women who start oral hormonal treatment and have an intra-uterine device
6. Postmenopausal women who start transdermal hormonal treatment and have an intra-uterine device
7. Postmenopausal women with breast cancer taking selective oestrogen receptor modulators
8. Postmenopausal women with breast cancer taking aromatase inhibitors
9. Postmenopausal women with breast cancer taking duavive
10. Postmenopausal women with no breast cancer and do not start with hormonal therapy
The questionnaires that needs to be completed are:
1. Mini Mental State Examination (only at the first visit)
2. Targeting Aetiology of Nocturia Guides Outcomes Short Form (TANGO-SF) (visit 1 and 2)
3. International Consultation of Incontinence Modular Questionnaire (ICIQ) (visit 1 and 2)
4. Perceived stress scale (Cohen) (visit 1 and 2)
5. Pittsburgh sleep quality
Датуми
| Последен пат проверено: | 12/31/2019 |
| Прво доставено: | 01/07/2020 |
| Поднесено е проценето запишување: | 03/16/2020 |
| Прво објавено: | 03/17/2020 |
| Последното ажурирање е доставено: | 05/10/2020 |
| Последно ажурирање објавено: | 05/11/2020 |
| Крај на датумот на започнување на студијата: | 04/16/2018 |
| Проценет датум на примарно завршување: | 06/29/2020 |
| Проценет датум на завршување на студијата: | 12/30/2020 |
Состојба или болест
Интервенција / третман
Procedure: blood take
Фаза
Групи за раце
| Рака | Интервенција / третман |
|---|---|
| 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. | |
| 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. | |
| 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. | |
| 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. | |
| 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. | |
| 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. | |
| 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. | |
| 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. | |
| 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. | |
| 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. |
Критериуми за подобност
| Возраст подобни за студии | 40 Years До 40 Years |
| Полови квалификувани за студии | Female |
| Прифаќа здрави волонтери | Да |
| Критериуми | 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 |
Исход
Мерки на примарниот исход
1. Degradation products of the Amyloid metabolism in blood [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 [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 [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 [2 years after the first patient was included, the first batch of samples will be analysed.]
5. Degradation products of the Amyloid metabolism in blood [2 years after the first patient was included, the first batch of samples will be analysed.]
6. Degradation products of the Amyloid metabolism in blood [2 years after the first patient was included, the first batch of samples will be analysed.]
7. APOE-genotyping in blood [2 years after the first patient was included, the first batch of samples will be analysed.]
8. identify BACE1 in blood [2 years after the first patient was included, the first batch of samples will be analysed.]
