Evaluation of Safety of Contraloid Acetate in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease
Status:
Recruiting
Trial end date:
2021-11-01
Target enrollment:
Participant gender:
Summary
Patients with mild cognitive impairment due to Alzheimer's disease (MCI due to AD) are at
high risk to develop Alzheimer´s dementia. The therapeutic agent Contraloid has the potential
to influence the chronic neurodegenerative process of AD. As Contraloid was so far only
administered to healthy subjects, the rational of the proposed study is first to collect
safety data in patients diagnosed with MCI due to AD, as the absorption, distribution,
metabolism and excretion processes may be altered by disease, aging, comorbidities and
concomitant drug therapies. Additionally, the design of a subsequent phase II study will be
based on the data of this study. The results of the exploratory analyses will enable power
calculations and the identification of the most useful and reliable biomarkers for the
subsequent proof of concept phase II study.
Phase:
Phase 1
Details
Lead Sponsor:
Charite University, Berlin, Germany
Collaborators:
Berlin Institute of Health Berlin Institute of Health, Germany Federal Agency for Disruptive Innovation - SPRIN-D Federal Agency For Disruptive Innovation, Germany