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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
19
Oral administration of drug substance capsules
Oral administration of placebo without any exipients.
Charité University Medicine
Berlin, Germany
Safety: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Number of Adverse Events
Time frame: From baseline (day 1) to follow-up (day 56)
Safety: Number of Participants with abnormal laboratory values (urinalysis, CBC, Quick, PTT, Creatinine, CK, CRP, ALT, AST)
Laboratory values: urinalysis, CBC, Quick, PTT, Creatinine, CK, CRP, ALT, AST
Time frame: From baseline (day 1) to follow-up (day 56)
Safety: Number of Participants with abnormal ECG values
ECG
Time frame: From baseline (day 1) to follow-up (day 56)
Pharmacokinetics: Peak Plasma Concentration (Cmax)
Cmax in plasma
Time frame: pre-dose and 15 min, 1 hour, 2 hours, 4 hours post-dose at day 1 and day 28
Pharmacokinetics: The time at which Cmax is observed (Tmax)
Tmax in plasma
Time frame: pre-dose and 15 min, 1 hour, 2 hours, 4 hours post-dose at day 1 and day 28
Pharmacokinetics: Terminal elimination half-life (t1/2) in plasma
t1/2 in plasma
Time frame: pre-dose and 15 min, 1 hour, 2 hours, 4 hours post-dose at day 1 and day 28
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