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 (AD) in Comparison to Healthy Volunteers

PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

November 24, 2017

Primary Completion Date

July 12, 2021

Study Completion Date

October 22, 2021

Conditions
Alzheimer Disease
Interventions
DRUG

TEP

"For safety reasons the clinical trial will first enroll 14 subjects (7 patients and 7 healthy volunteers) for Group 1a receiving 26 mg TEP daily for 4 days with subsequent safety evaluation, based on adverse events and the safety parameters discussed in the protocol. A second set of patients (Group 1b), which will receive a higher dosage of 52 mg per day for 4 days will be enrolled optionally after recommendation to continue and subsequently treatment Group 2 with a treatment paradigm of 26 mg TEP daily for 54 days will start.~Subjects eligible for participation are subjects with newly diagnosed (within last 12 month) early-to-mild dementia due to AD and healthy volunteers who fulfill all inclusion criteria and have none of the exclusion criteria present at screening."

Trial Locations (2)

37075

Klinik für Psychiatrie und Psychotherapie Universitätsmedizin Göttingen, Göttingen

68159

Zentralinstitut für seelische Gesundheit, Medizinische Fakultät Mannheim, Universität Heidelberg,, Mannheim

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Immungenetics AG

INDUSTRY