Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT02472028 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Blood Pressure Reduction to Limit the Evolution of Vascular Brain Lesions in Elderly Individuals

Study acronym: LEOPOLD
StatusRecruiting
PhasePhase 4
Started2015-09
View on ClinicalTrials.gov ↗

Amendment history

2025-09-04
2 amendments v8-v9
2 re-verifications since 2024-05-13, no change to tracked fields
2024-04-03
Study Status v7
Primary completion date2026-09-11→2028-09-11
Completion date2026-09-11→2028-09-11
2022-09-20
Study Status, Study Description, Outcome Measures v6
Primary completion date2024-09-11→2026-09-11
Completion date2024-09-11→2026-09-11
Secondary endpointsdetails revised at 6 of 10 entries
Study description+19 characters
[...] RI. CONDUCT OF THE STUDY: Duration of the inclusion period: 7196 months and 2 weeks. Patient participation duration: 36 months +/- 26 weeksmonths max Total study duration: 911 years. Clinical and para-clinical evaluation: MRI as part o [...] ng of the study and before the end of the study at 36 months + 6 months max (primary endpoint); Clinical evaluation of neuropsychologic [...]
2021-04-29
Study Status v5
Re-verified, no change to tracked fields
2020-05-11
Study Status, Study Description v4
Primary completion date2019-01→2024-09-11
Completion date2019-01→2024-09-11
Study description-4 characters
[...] usual strategy based on the usual routine care. SAMPLE SIZE: 820 patients will be enrolled (410 in each arm) in 12 Memory Re [...] RI. CONDUCT OF THE STUDY: Duration of the inclusion period: 4771 months and 2 weeks. Patient participation duration: 36 months +/- 2 weeks Total study duration: 79 years. Clinical and para-clinical evaluation: MRI as part o [...]
Show 3 earlier versions
2018-11-14
Study Status, Study Description, Eligibility v3
Eligibility criteria+39 characters
[...] mHg, treated or not Affiliation to a social security system Informed consent given, signed consent Exclusion Criteria: Presence of severe orthostatic hypotensi [...]
Study description-11 characters
[...] LE SIZE: 820 patients will be enrolled (410 in each arm) in 2512 Memory Resources and Research Center (CMRR) with access to [...] RI. CONDUCT OF THE STUDY: Duration of the inclusion period: 2347 months and 2 weeks. Patient participation duration: 36 months +/- 2 weeks Total study duration: 57 years. Clinical and para-clinical evaluation: MRI as part o [...] tes, lipid profiles, fasting blood glucose, if not existing); MRI if not existing (- 5 years) for validation of the inclusion criterion and performed in the ordinary course.
2016-06-30
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Eligibility criteria+38 characters
Inclusion Criteria: 60 to 8588 years old patients; Patient with cognitive complaint with MMSE ≥ 2020performed within 6 months prior to enrollment (with or without dementia) Patient with a socio-educational [...] hyperintensities of moderate to high grade on the last MRI (underor 5old years)scan (grades C and D on the modified Scheltens scale, grades 2/3 [...] iastolic Blood Pressure (DBP) ≥ 140/90 mmHg, treated or not Absence of severe renal impairment Affiliation to a social security system Exclusion Criteria: [...] mentia different than Alzheimer's disease vascular dementia Lewy Body or mixed dementia, Persons [...] [...]
Study sitesdetails revised at 2 of 2 sites
2015-07-07
Study Status v1
Primary completion date2018-10→2019-01
Completion date2018-10→2019-01
Start date2015-06→2015-09
2015-06-10
Original filing
The purpose of the study is to test the hypothesis of slowing the progression of White Matter Lesions (WML) by lowering blood pressure (BP) in patients with cognitive complaints and a moderate to high grade of WML on brain MRI.
Trial Details
NCT Number NCT02472028
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions Cerebrovascular Disorders
Enrollment 820 participants
Start Date 2015-09
Primary Completion 2028-09-11 (estimated)
Study Completion 2028-09-11 (estimated)
Updated on ClinicalTrials.gov 2025-09-05