Trial of Simvastatin in Amnestic Mild Cognitive Impairment (MCI) Patients (SIMaMCI)
Randomized Controlled Trial of Simvastatin in Amnestic MCI Patients
Sponsor: Charite University, Berlin, Germany
A PHASE4 clinical study on Mild Cognitive Impairment, this trial is ongoing. The trial is conducted by Charite University, Berlin, Germany and has accumulated 11 data snapshots since 2008. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)This is a national multicenter, double-blind, randomized placebo-controlled trial allowing for a minimum follow-up time of 24 months in conversion-free patients. Randomization will be stratified by prior use of statins.
The two strata are:
1. "no-statins": patients without treatment with a statins and no indication for treatment (according to the guidelines of the German Society of Cardiology for the primary prevention of cardiovascular disease); patients will be randomly assigned to one of 2 treatment (1) Simvastatin (60 mg) one tablet/day (2) Placebo one tablet/day.
2. "low-statins": patients treated with low doses of Statins; patients will be randomly assigned to one of 2 treatment (1) Simvastatin (60 mg) one tablet/day (2) 20 mg Simvastatin one tablet/day.
This is a national multicenter, double-blind, randomized placebo-controlled trial allowing for a minimum follow-up time of 24 months in conversion-free patients. Randomization will be stratified by prior use of statins.
The two strata are:
1. "no-statins": patients without treatment with a statins and no indication for treatment (according to the guidelines of the German Society of Cardiology for the primary prevention of cardiovascular disease); patients will be randomly assigned to one of 2 treatment (1) Simvastatin (60 mg) one tablet/day (2) Placebo one tablet/day. 2. "low-statins": patients treated with low doses of Statins; patients will be randomly assigned to one of 2 treatment (1) Simvastatin (60 mg) one tablet/day (2) 20 mg Simvastatin one tablet/day.
Status Flow
Change History
11 versions recorded-
Jan 2026 — Present [monthly]
Unknown PHASE4
-
Sep 2025 — Present [monthly]
Unknown PHASE4
-
Sep 2024 — Sep 2025 [monthly]
Unknown PHASE4
-
Jul 2024 — Sep 2024 [monthly]
Unknown PHASE4
Status: Unknown Status → Unknown
-
Mar 2022 — Jul 2024 [monthly]
Unknown Status PHASE4
Status: Active Not Recruiting → Unknown Status
▶ Show 6 earlier versions
-
Jan 2021 — Mar 2022 [monthly]
Active Not Recruiting PHASE4
-
Feb 2020 — Jan 2021 [monthly]
Active Not Recruiting PHASE4
Status: Recruiting → Active Not Recruiting
-
Oct 2019 — Feb 2020 [monthly]
Recruiting PHASE4
Status: Unknown Status → Recruiting
-
Apr 2019 — Oct 2019 [monthly]
Unknown Status PHASE4
Status: Recruiting → Unknown Status
-
Jun 2018 — Apr 2019 [monthly]
Recruiting PHASE4
-
Jan 2017 — Jun 2018 [monthly]
Recruiting PHASE4
First recorded
Dec 2008
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Charite University, Berlin, Germany
- German Federal Ministry of Education and Research
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Berlin, Germany , Bonn, Germany , Erlangen, Germany , Frankfurt am Main, Germany , Freiburg im Breisgau, Germany , Göttingen, Germany , Halle, Germany , Heidelberg, Germany , Mannheim, Germany , Munich, Germany and 2 more locations