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NCT Number: NCT04711486

Evaluation of Safety of Contraloid Acetate in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease

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.

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Key information

Conditions

Mild Cognitive Impairment Due to Alzheimer's Disease

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Charité University Medicine

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Persons who may be dependent on the sponsor, the investigator or the trial site
  • Persons without caregiver
  • Participation in other clinical trials according to AMG (1 month before the time of this trial)
  • Persons showing EEG abnormalities

Treatment and study plan

Contraloid acetate

Drug

Oral administration of drug substance capsules

Other names: PRI-002

Placebo

Drug

Oral administration of placebo without any exipients.

Other names: Microcrystalline cellulose

Primary outcomes

  1. 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

  2. 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

  3. Safety: Number of Participants with abnormal ECG values

    Time frame: From baseline (day 1) to follow-up (day 56)

    ECG

Secondary outcomes

  1. Pharmacokinetics: Peak Plasma Concentration (Cmax)

    Time frame: pre-dose and 15 min, 1 hour, 2 hours, 4 hours post-dose at day 1 and day 28

    Cmax in plasma

  2. Pharmacokinetics: The time at which Cmax is observed (Tmax)

    Time frame: pre-dose and 15 min, 1 hour, 2 hours, 4 hours post-dose at day 1 and day 28

    Tmax in plasma

  3. Pharmacokinetics: Terminal elimination half-life (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

    t1/2 in plasma

Other outcomes

  1. Efficacy: Change of biomarkers in CSF

    Time frame: 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

  2. Efficacy: Change of biomarkers in plasma

    Time frame: 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

  3. Efficacy optional: Change of biomarkers in feces

    Time frame: 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

  4. Efficacy: Change in CERAD+ test battery scores

    Time frame: Baseline to end of treatment (day 28) to follow-up (day 56)

  5. Efficacy: Change in CDR-Sum of boxes

    Time frame: Baseline to end of treatment (day 28) to follow-up (day 56)

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Berlin Institute of Health
  • Federal Agency for Disruptive Innovation - SPRIN-D

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 15, 2021
Registry last updated
Aug 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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