A Single-centre, Randomized, Placebo-controlled, Double-blind, Phase 1b Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Contraloid Acetate in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease
Overview
- Phase
- Phase 1
- Intervention
- Contraloid acetate
- Conditions
- Mild Cognitive Impairment Due to Alzheimer's Disease
- Sponsor
- Charite University, Berlin, Germany
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Safety: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Oliver Peters, MD
Principal Investigator
Charite University, Berlin, Germany
Eligibility Criteria
Inclusion Criteria
- •Patients diagnosed with MCI due to AD according to DSM-V
- •Age between 50 and 80 years (male and female)
- •MMSE score 22-30
- •Written informed consent (according AMG §40 (1) 3b)
- •Level of Aβ-oligomers: mind. 1fM
- •CSF according to diagnosis (p-tau \> 62 pg/ml, total CSF Aβ 1-42/1-40 ratio ≤ 0.055)
- •3 months prior to screening stable medication
- •Females without childbearing potential
Exclusion Criteria
- •History of seizures
- •History of stroke or TIA
- •Unstable medical, neurological or psychiatric condition
- •Current treatment with one of the following substances:
- •Typical antipsychotic or neuroleptic medication within 6 months of screening
- •Anti-coagulation medications within 3 months of screening
- •Chronic use of opiates or opioids (including long-acting opioid medication) within 3 months of screening
- •Stimulant medications (amphetamine, methylphenidate preparations, or modafinil) within 1 month of screening and throughout the study
- •Chronic use of benzodiazepines, barbiturates, or hypnotics from 3 months before screening
- •Persons who are legally detained in an official institution
Arms & Interventions
Contraloid acetate
300 mg Contraloid/participant administered orally (for 28 days) as a single daily dose. Other Name: PRI-002
Intervention: Contraloid acetate
Placebo
300 mg Placebo (Microcrystalline cellulose)/participant administered orally (for 28 days) as a single daily dose.
Intervention: Placebo
Outcomes
Primary Outcomes
Safety: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time Frame: From baseline (day 1) to follow-up (day 56)
Number of Adverse Events
Safety: Number of Participants with abnormal laboratory values (urinalysis, CBC, Quick, PTT, Creatinine, CK, CRP, ALT, AST)
Time Frame: From baseline (day 1) to follow-up (day 56)
Laboratory values: urinalysis, CBC, Quick, PTT, Creatinine, CK, CRP, ALT, AST
Safety: Number of Participants with abnormal ECG values
Time Frame: From baseline (day 1) to follow-up (day 56)
ECG
Secondary Outcomes
- Pharmacokinetics: Peak Plasma Concentration (Cmax)(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)(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(pre-dose and 15 min, 1 hour, 2 hours, 4 hours post-dose at day 1 and day 28)