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| ID | Type | Description | Link |
|---|---|---|---|
| BMBF grant, 01KG0822 |
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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
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Probands with MCI are at high risk to develop Alzheimer´s dementia (AD). Simvastatin may lower the production of Amyloid, a hallmark of AD in the brain. The primary hypothesis of the study is that 60 mg Simvastatin significantly reduces the Clinical Dementia Rating -Sum of boxes (CDR-SOB) in individuals with MCI as compared to MCI receiving placebo or 20 mg Simvastatin
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo or 20 mg Simvastatin (stratified by prior use of statins) |
|
| Simvastatin 60 mg | Experimental | Simvastatin 60 mg once daily |
|
| Simvastatin 20 mg | Experimental | Simvastatin 20 mg once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin 60 mg | Drug | 60 mg once daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CDR-SOB at 24 months of treatment | Clinical dementia rating - sum of boxes | 24 month |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score | 24 month | |
| Change in Free and Cued Selective Reminding Test (FCSRT) score | 24 month | |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CDR-SOB at Long-Term Follow-Up | 2-11 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabella Heuser, MD, PhD | Charité-CBF | Principal Investigator |
| Lutz Frölich, MD | CIMH Mannheim | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry and Psychotherapy, Charité-CBF | Berlin | Germany | ||||
| Department of Psychiatry and Psychotherapy, University Bonn |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Drug |
one tablet once daily |
|
| Simvastatin 20 mg | Drug | 20 mg once daily |
|
| Length of conversion-free interval, starting at the time of randomization, with conversion being defined as an increase of the CDR score beyond 0.5 |
| 24 months |
| Bonn |
| 53105 |
| Germany |
| Department of Psychiatry and Psychotherapy, University Erlangen | Erlangen | 91054 | Germany |
| Department of Psychiatry and Psychotherapy, Johann Wolfgang Goethe-University | Frankfurt am Main | 60528 | Germany |
| Center for Geriatrics and Gerontology, University Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Department of Psychiatry and Psychotherapy, Medical University Goettingen | Göttingen | 37075 | Germany |
| Department for Psychiatry, Psychotherapy and Psychosomatic; Martin-Luther-University Halle-Wittenberg | Halle | 06112 | Germany |
| Department of Psychiatry, University Hospital Heidelberg | Heidelberg | 69115 | Germany |
| Department of Gerontopsychiatry, Central Institut of Mental Health, University Heidelberg | Mannheim | 68072 | Germany |
| Department of Psychiatry and Psychotherapy, LMU I | Munich | 80336 | Germany |
| Institute for Stroke and Dementia Research, LMU | Munich | 81377 | Germany |
| Department of Psychiatry and Psychotherapy, University Rostock | Rostock | Germany |
| Neurologische Universitätsklinik Ulm | Ulm | 89081 | Germany |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |