NCT04312399

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Apr 2018Dec 2028

Study Start

First participant enrolled

April 17, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

9.7 years

First QC Date

January 8, 2020

Last Update Submit

January 22, 2025

Conditions

Postmenopausal SymptomsAlzheimer Disease

Outcome Measures

Primary Outcomes (8)

  • 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

    2 years after the first patient was included, the first batch of samples will be analysed.

  • 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

    2 years after the first patient was included, the first batch of samples will be analysed.

  • 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

    2 years after the first patient was included, the first batch of samples will be analysed.

  • 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

    2 years after the first patient was included, the first batch of samples will be analysed.

  • 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

    2 years after the first patient was included, the first batch of samples will be analysed.

  • 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

    2 years after the first patient was included, the first batch of samples will be analysed.

  • 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

    2 years after the first patient was included, the first batch of samples will be analysed.

  • 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.

    2 years after the first patient was included, the first batch of samples will be analysed.

Study Arms (10)

oral hormonal therapy

OTHER

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 (and 12) months after the start of the therapy blood will be taken for analysis. At the 2/3 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

transdermal hormonal therapy

OTHER

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 (and 12) months after the start of the therapy blood will be taken for analysis. At the 2/3 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

oral hormonal therapy + hysterectomy

OTHER

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 (and 12) months after the start of the therapy blood will be taken for analysis. At the 2/3 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

transdermal hormonal therapy + hysterectomy

OTHER

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 (and 12) months after the start of the therapy blood will be taken for analysis. At the 2/3 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

oral hormonal therapy + IUD

OTHER

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 (and 12) months after the start of the therapy blood will be taken for analysis. At the 2/3 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

transdermal hormonal therapy + IUD

OTHER

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 (and 12) months after the start of the therapy blood will be taken for analysis. At the 2/3 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

selective oestrogenreceptor modulators

OTHER

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 (and 12) months after the start of the therapy blood will be taken for analysis. At the 2/3 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

aromatase inhibitors

OTHER

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 (and 12) months after the start of the therapy blood will be taken for analysis. At the 2/3 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

Duavive

OTHER

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 (and 12) months after the start of the therapy blood will be taken for analysis. At the 2/3 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

Control

OTHER

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 (and 12) months after the start of the therapy blood will be taken for analysis. At the 2/3 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

Interventions

blood takePROCEDURE

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

ControlDuavivearomatase inhibitorsoral hormonal therapyoral hormonal therapy + IUDoral hormonal therapy + hysterectomyselective oestrogenreceptor modulatorstransdermal hormonal therapytransdermal hormonal therapy + IUDtransdermal hormonal therapy + hysterectomy

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • postmenopausal women
  • years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent university hospital

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Herman Depypere, MD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eline Meireson, Msc

CONTACT

0032 9 332 78 17eline.meireson@uzgent.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 10 study groups: 9 groups who start with hormonal treatment and 1 control group who doesn't start with hormonal treatment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2020

First Posted

March 18, 2020

Study Start

April 17, 2018

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

January 27, 2025

Record last verified: 2025-01

Locations

BE(1)