Immungenetics AG
This proof-of-mechanism clinical trial study will test the efficacy and safety of thiethylperazine (TEP) in subjects with early onset of Alzheimer's Disease (AD). There is a strong scientific rationale for this study: TEP is a very well-known substance that has been available since 1961 and approved for the prevention and treatment of nausea, vomiting as well as vertigo. Therefore, it has a well understood pharmacologic background and promising safety data. Using AD mouse models, it has been recently discovered and confirmed that TEP promotes transport of toxic Aβ from the brain into the blood. More importantly, it has also been demonstrated to improve learning deficits in mice. The striking biological effect of TEP in preclinical testing and its known safety and toxicity profile encourages the investigators to investigate this in a multicenter clinical trial in subjects with early-to-mild AD in comparison to healthy volunteers. The investigators will assess whether TEP is able to enhance the transport of Aβ peptides from the brain into the blood in subjects with early-to-mild AD and improves cognitive efficacy.
Alzheimer Disease
TEP
PHASE2
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 20 participants |
Masking : | NONE |
Primary Purpose : | TREATMENT |
Official Title : | An Open-label, Multicenter, Controlled Pharmaco-dynamic Clinical Trial to Explore the the Amyloid Beta Draining Effect of Thiethylperazine (TEP) in Subjects With Newly Diagnosed Early-to-mild Dementia Due to Alzheimer's Disease in Comparison to Healthy Volunteers |
Actual Study Start Date : | 2017-11-24 |
Estimated Primary Completion Date : | 2021-07-12 |
Estimated Study Completion Date : | 2021-10-22 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 55 Years to 75 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Clinic for Psychiatry and Psychotherapy University Medical Center Göttingen
Göttingen, Germany, 37075
Not yet recruiting
Central Institute for Mental Health, Mannheim Medical Faculty, Heidelberg University,
Mannheim, Germany, 68159