Evaluation of Safety of Contraloid Acetate in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Contraloid acetate 300 mg Contraloid/participant administered orally (for 28 days) as a single daily dose. Other Name: PRI-002 |
Drug: Contraloid acetate
Oral administration of drug substance capsules
Other Names:
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Placebo Comparator: Placebo 300 mg Placebo (Microcrystalline cellulose)/participant administered orally (for 28 days) as a single daily dose. |
Drug: Placebo
Oral administration of placebo without any exipients.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Safety: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [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) [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 [From baseline (day 1) to follow-up (day 56)]
ECG
Secondary Outcome Measures
- Pharmacokinetics: Peak Plasma Concentration (Cmax) [pre-dose and 15 min, 1 hour, 2 hours, 4 hours post-dose at day 1 and day 28]
Cmax in plasma
- 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]
Tmax in plasma
- 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]
t1/2 in plasma
Other Outcome Measures
- Efficacy: Change of biomarkers in CSF [Baseline to end of treatment (day 28) to follow-up (day 56)]
Biomarkers: p-tau, t-tau, NFL, Aβ 1-40, Aβ 1-42 and Aβ and tau oligomers
- Efficacy: Change of biomarkers in plasma [Baseline to end of treatment (day 28) to follow-up (day 56)]
Biomarkers: p-tau, t-tau, NFL, Aβ 1-40, Aβ 1-42 and Aβ and tau oligomers
- Efficacy optional: Change of biomarkers in feces [Baseline to end of treatment (day 28) to follow-up (day 56)]
Biomarkers: p-tau, t-tau, NFL, Aβ 1-40, Aβ 1-42 and Aβ and tau oligomers
- Efficacy: Change in CERAD+ test battery scores [Baseline to end of treatment (day 28) to follow-up (day 56)]
- Efficacy: Change in CDR-Sum of boxes [Baseline to end of treatment (day 28) to follow-up (day 56)]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients diagnosed with MCI due to AD according to DSM-V
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Age between 50 and 80 years (male and female)
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MMSE score 22-30
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Written informed consent (according AMG §40 (1) 3b)
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Level of Aβ-oligomers: mind. 1fM
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CSF according to diagnosis (p-tau > 62 pg/ml, total CSF Aβ 1-42/1-40 ratio ≤ 0.055)
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3 months prior to screening stable medication
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Females without childbearing potential
Exclusion Criteria:
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History of seizures
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History of stroke or TIA
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Unstable medical, neurological or psychiatric condition
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Current treatment with one of the following substances:
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Typical antipsychotic or neuroleptic medication within 6 months of screening
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Anti-coagulation medications within 3 months of screening
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Chronic use of opiates or opioids (including long-acting opioid medication) within 3 months of screening
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Stimulant medications (amphetamine, methylphenidate preparations, or modafinil) within 1 month of screening and throughout the study
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Chronic use of benzodiazepines, barbiturates, or hypnotics from 3 months before screening
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Persons who are legally detained in an official institution
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Persons who may be dependent on the sponsor, the investigator or the trial site
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Persons without caregiver
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Participation in other clinical trials according to AMG (1 month before the time of this trial)
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Persons showing EEG abnormalities
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Charité University Medicine | Berlin | Germany | 10117 |
Sponsors and Collaborators
- Charite University, Berlin, Germany
- Berlin Institute of Health
- Federal Agency for Disruptive Innovation - SPRIN-D
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ContraloidAD