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

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ClinicalTrials.gov Identifier: NCT04711486
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : January 15, 2021
Sponsor:
Collaborators:
Berlin Institute of Health, Germany
Federal Agency For Disruptive Innovation, Germany
Information provided by (Responsible Party):
Oliver Peters, MD, Charite University, Berlin, Germany

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
Mild Cognitive Impairment Due to Alzheimer's Disease Drug: Contraloid acetate Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 8, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: PRI-002

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 Name: Microcrystalline cellulose




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04711486


Contacts
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Contact: Oliver Peters, Prof. +4930450517628 oliver.peters@charite.de

Locations
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Germany
Charité University Medicine Recruiting
Berlin, Germany, 10117
Contact: Oliver Peters, Prof.    +4930450517628    oliver.peters@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
Berlin Institute of Health, Germany
Federal Agency For Disruptive Innovation, Germany
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Responsible Party: Oliver Peters, MD, Principal Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT04711486    
Other Study ID Numbers: ContraloidAD
First Posted: January 15, 2021    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders