Clinical trial NCT04711486: Evaluation of Safety of Contraloid Acetate in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mild Cognitive Impairment Due to Alzheimer's Disease
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Berlin Institute of Health
name: Federal Agency for Disruptive Innovation - SPRIN-D
First posted: 2021-01-15
Enrollment: 19
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with MCI due to AD according to DSM-V
2. Age between 50 and 80 years (male and female)
3. MMSE score 22-30
4. Written informed consent (according AMG §40 (1) 3b)
5. Level of Aβ-oligomers: mind. 1fM
6. CSF according to diagnosis (p-tau \> 62 pg/ml, total CSF Aβ 1-42/1-40 ratio ≤ 0.055)
7. 3 months prior to screening stable medication
8. Females without childbearing potential

Exclusion Criteria:

1. History of seizures
2. History of stroke or TIA
3. Unstable medical, neurological or psychiatric condition
4. 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
5. Persons who are legally detained in an official institution
6. Persons who may be dependent on the sponsor, the investigator or the trial site
7. Persons without caregiver
8. Participation in other clinical trials according to AMG (1 month before the time of this trial)
9. Persons showing EEG abnormalities

Primary outcomes:
measure: Safety: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
timeFrame: From baseline (day 1) to follow-up (day 56)
measure: Safety: Number of Participants with abnormal laboratory values (urinalysis, CBC, Quick, PTT, Creatinine, CK, CRP, ALT, AST)
timeFrame: From baseline (day 1) to follow-up (day 56)
measure: Safety: Number of Participants with abnormal ECG values
timeFrame: From baseline (day 1) to follow-up (day 56)
Secondary outcomes:
measure: Pharmacokinetics: Peak Plasma Concentration (Cmax)
timeFrame: pre-dose and 15 min, 1 hour, 2 hours, 4 hours post-dose at day 1 and day 28
measure: Pharmacokinetics: The time at which Cmax is observed (Tmax)
timeFrame: pre-dose and 15 min, 1 hour, 2 hours, 4 hours post-dose at day 1 and day 28
measure: Pharmacokinetics: Terminal elimination half-life (t1/2) in plasma
timeFrame: pre-dose and 15 min, 1 hour, 2 hours, 4 hours post-dose at day 1 and day 28
Other outcomes:
measure: Efficacy: Change of biomarkers in CSF
timeFrame: Baseline to end of treatment (day 28) to follow-up (day 56)
measure: Efficacy: Change of biomarkers in plasma
timeFrame: Baseline to end of treatment (day 28) to follow-up (day 56)
measure: Efficacy optional: Change of biomarkers in feces
timeFrame: Baseline to end of treatment (day 28) to follow-up (day 56)
measure: Efficacy: Change in CERAD+ test battery scores
timeFrame: Baseline to end of treatment (day 28) to follow-up (day 56)
measure: Efficacy: Change in CDR-Sum of boxes
timeFrame: Baseline to end of treatment (day 28) to follow-up (day 56)
Locations:
city: Berlin
country: Germany
facility: Charité University Medicine
Study officials:
References: