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Trial · Interventional

CompletedPhase 2Registry data

Study to Evaluate Safety, Tolerability, and Effect of AL208 on Mild Cognitive Impairment Following Coronary Artery Bypass Graft Surgery

Overview

Status
Completed
Phase
Phase 2
Enrollment
234 participants (actual)
Sponsor
Allon Therapeutics · Industry
Design
Randomized · Quadruple masking
Countries
2 countries

United States, Canada

Start
Aug 2006
Primary completion
Jun 2008
Completion
Jun 2008
First posted
27 Nov 2006 (estimated)
Last update posted
24 Oct 2012 (estimated)
Conditions
Mild Cognitive Impairment

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2006200720082009
  1. Ph 2

    Study to Evaluate Safety, Tolerability, and Effect of AL208 on Mild Cognitive Impairment Following Coronary Artery Bypass Graft Surgery

    NCT00404014

    Aug 2006 to Jun 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The primary objective is to compare mild cognitive impairment in the AL-208 group with the placebo group at 14 + - 3 days after CABG surgery

Interventions

  • AL-208Drug
  • PlaceboDrug

Arms2

  • Active comparator

    AL-208

    1 dose of 300 mg

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The primary objective of this study was to compare mild cognitive impairment in the AL-208 group with the placebo group at 14±3 days after coronary artery bypass graft (CABG) surgery.

    Time frame · 14 days

    Registry description

    The primary objective of this study was to compare mild cognitive impairment in the AL-208 group with the placebo group at 14±3 days after coronary artery bypass graft (CABG) surgery.

Secondary outcomes(3)
  1. The safety profile of AL-208 in subjects undergoing CABG surgery

    Time frame · 14 days

    Registry description

    The safety profile of AL-208 in subjects undergoing CABG surgery

  2. The effect of treatment with AL-208 on postoperative personality changes in subjects undergoing CABG surgery

    Time frame · 14 days

    Registry description

    The effect of treatment with AL-208 on postoperative personality changes in subjects undergoing CABG surgery

  3. Concentration of AL-208 in plasma in subjects undergoing CABG surgery

    Time frame · 14 days

    Registry description

    Concentration of AL-208 in plasma in subjects undergoing CABG surgery

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2025

4 results

Systemic davunetide provides sex-specific neuroprotection during Coronary Artery Bypass Grafting (CABG).

Gozes et al. 2025Translational psychiatrycited by 5

PMID 41173865PMC12578781DOI 10.1038/s41398-025-03675-yPUB-41173865

Free to read · publisher termsCC BY-NC-ND4 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 50 Years up to 79 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Males and females (of non-childbearing potential), 50 to 79 years of age. 2. Undergoing CABG surgery with the use of extracorporeal circulation. 3. Willing and able to complete cognitive testing. 4. Score \< 16 on the Center for Epidemiological Studies in Depression scale (CES-D). 5. Score \> or = 28 on the Mini-Mental State Examination (MMSE). 6. Willing and able to provide informed consent to participate in this study 7. Fluency in written and spoken English. Exclusion Criteria: 1. Presence of any severe mental illness that could affect interpretation of efficacy data, such as schizophrenia or bipolar affective disorder; any untreated or unstable psychiatric condition including depressive disorder or anxiety disorder. 2. History of stroke or other significant neurological disorder 3. Transient ischemic attack (TIA) with ongoing cognitive sequelae 4. Chronic atrial fibrillation or uncontrolled atrial fibrillation prior to surgery 5. Myocardial infarction (MI) within the last 8 weeks and/or previous history of more than 3 MIs 6. History of liver dysfunction with ongoing sequelae (including but not limited to liver enzymes \> 2.5 x upper limit or normal (ULN) at screening). 7. History of renal dysfunction with ongoing sequelae (including but not limited to creatinine value \> 2.5 mg/dL at screening). 8. Known active alcohol or drug abuse. 9. Concurrent use of prescription medications known to enhance memory 10. General anesthesia (defined as anesthesia requiring intubation or ventilatory support) within 3 months prior to randomization. 11. Cardiopulmonary bypass or thoracotomy within 2 years prior to randomization. 12. Undergoing valvular repair or replacement during scheduled CABG surgery. 13. Chronic obstructive pulmonary disease (COPD) requiring oxygen therapy. 14. Decompensating congestive heart disease 15. Subjects on immunosuppressive drugs, such as azathioprine, chemotherapeutic agents, mycophenolate, monoclonal antibodies, or more than 20 mg/day prednisone, within the previous 3 months 16. Receipt of any investigational agent or device within 30 days of screening.

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