Mild Cognitive ImpairmentPhase 2NCT00404014
Study to Evaluate Safety, Tolerability, and Effect of AL208 on Mild Cognitive Impairment Following Coronary Artery Bypass Graft Surgery
A Phase 2 study testing AL-208 in people with Mild Cognitive Impairment, run by Allon Therapeutics at 28 sites in 2 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 50 to 79 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- AL-208
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 234 participants
- Where
- 28 sitesin 2 countries
- Study dates
- Aug 2006to Jun 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females (of non-childbearing potential), 50 to 79 years of age.
- Undergoing CABG surgery with the use of extracorporeal circulation.
- Willing and able to complete cognitive testing.
- Score < 16 on the Center for Epidemiological Studies in Depression scale (CES-D).
- Score > or = 28 on the Mini-Mental State Examination (MMSE).
- Willing and able to provide informed consent to participate in this study
- Fluency in written and spoken English.
Who cannot join
- 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.
- History of stroke or other significant neurological disorder
- Transient ischemic attack (TIA) with ongoing cognitive sequelae
- Chronic atrial fibrillation or uncontrolled atrial fibrillation prior to surgery
- Myocardial infarction (MI) within the last 8 weeks and/or previous history of more than 3 MIs
- History of liver dysfunction with ongoing sequelae (including but not limited to liver enzymes > 2.5 x upper limit or normal (ULN) at screening).
Show all 16Show fewer
- History of renal dysfunction with ongoing sequelae (including but not limited to creatinine value > 2.5 mg/dL at screening).
- Known active alcohol or drug abuse.
- Concurrent use of prescription medications known to enhance memory
- General anesthesia (defined as anesthesia requiring intubation or ventilatory support) within 3 months prior to randomization.
- Cardiopulmonary bypass or thoracotomy within 2 years prior to randomization.
- Undergoing valvular repair or replacement during scheduled CABG surgery.
- Chronic obstructive pulmonary disease (COPD) requiring oxygen therapy.
- Decompensating congestive heart disease
- Subjects on immunosuppressive drugs, such as azathioprine, chemotherapeutic agents, mycophenolate, monoclonal antibodies, or more than 20 mg/day prednisone, within the previous 3 months
- Receipt of any investigational agent or device within 30 days of screening.
Trial locations and contacts
28 sites in 2 countries.
28 sites in 2 countries
United States26 sites
Piedmont Hospital Research Institute
Atlanta, Georgia, 30309
The Atlanta Heart and Vascular Research Group
Atlanta, Georgia, 30342
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Rush University Medical Center
Chicago, Illinois, 60612
Clinical Cardiovascular Research Center
Dallas, Texas, 75226
Duke University Medical Center
Durham, North Carolina, 27710
Chicago Heart Institute and Vein Clinic
Elk Grove Village, Illinois, 60007
Consultants in Cardiovascular Diseases Inc.
Erie, Pennsylvania, 16502
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Cardiothoracic Associates
Flint, Michigan, 48532
Indiana/Ohio Heart Cardiothoracic and Vascular Surgeons
Fort Wayne, Indiana, 46804
Illinois Heart and Vascular Foundation
Hindsdale, Illinois, 60521
St. Luke's Episcopal Hospital
Houston, Texas, 77030
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Clinical Research Solutions, PC
Knoxville, Tennessee, 37920
Physicians Clinical Research Corp.
Laguna Hills, California, 92653
Cardiac and Thoracic Surgical Associates, Ltd.
Mechanicsville, Virginia, 23116
Vanderbilt University
Nashville, Tennessee, 37212
NYU Medical Center
New York, New York, 10016
Carolina Cardiovascular Surgical Associates, PA
Raleigh, North Carolina, 27610
Sacramento Heart and Vascular Research Center
Sacramento, California, 95825
Miami Research Associates
South Miami, Florida, 33143
Multicare Health Systems
Tacoma, Washington, 98415
St. Vincent Mary Medical Center
Toledo, Ohio, 43608
Tulsa Clinical Resesarch, LLC
Tulsa, Oklahoma, 74104-5428
Memory Assessment and Research Services
Wilmington, North Carolina, 28405
Canada2 sites
London health Sciences Centre
London, Ontario, N6A5A5
Toronto General Hospital
Toronto, Ontario, M5G2C4
About this study
Official title: A Phase II Study Designed to Evaluate the Safety, Tolerability, and Effect of a Single, Rising Dose of Intravenous AL-208, Followed by a Placebo-Controlled, Double-Blind, Parallel-Group Evaluation of a Single Dose of AL-208, on Mild Cognitive Impairment Following Coronary Artery Bypass Graft Surgery.
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
- Conditions
- Mild Cognitive Impairment
- Being tested
- AL-208, Placebo
- Keywords
- MCI following CABG surgery
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL-208Drug
1 dose of 300 mg
PlaceboDrug
1 dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| AL-208 | Active comparator | 1 dose of 300 mg Receives: Drug: AL-208 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 14 days
Secondary outcomes (3)
The safety profile of AL-208 in subjects undergoing CABG surgery
The safety profile of AL-208 in subjects undergoing CABG surgery
Measured: 14 days
The effect of treatment with AL-208 on postoperative personality changes in subjects undergoing CABG surgery
The effect of treatment with AL-208 on postoperative personality changes in subjects undergoing CABG surgery
Measured: 14 days
Concentration of AL-208 in plasma in subjects undergoing CABG surgery
Concentration of AL-208 in plasma in subjects undergoing CABG surgery
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2006 (estimated)
- Study startAug 2006
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allon Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elena Matthews, MD, Study director, Medical Monitor on behalf of Allon Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00404014
- Sponsor's protocol ID
- AL 208-201
- Status last verified
- Oct 2012
- First submitted
- 24 Nov 2006
- Last updated
- 24 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Gozes I, Blatt J, Guz LS. Systemic davunetide provides sex-specific neuroprotection during Coronary Artery Bypass Grafting (CABG). Transl Psychiatry. 2025 Oct 31;15(1):454. doi: 10.1038/s41398-025-03675-y.
PubMed 41173865
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Designed to Evaluate the Safety, Tolerability, and Effect of a Single, Rising Dose of Intravenous AL-208, Followed by a Placebo-Controlled, Double-Blind, Parallel-Group Evaluation of a Single Dose of AL-208, on Mild Cognitive Impairment Following Coronary Artery Bypass Graft Surgery.
- ClinicalTrials.gov ID
- NCT00404014
- Acronym / sponsor ID
- AL 208-201
- Conditions
- Mild Cognitive Impairment
- Keywords
- MCI following CABG surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Allon TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 27 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AL-208 | Active comparator | Drug: AL-2081 dose of 300 mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females (of non-childbearing potential), 50 to 79 years of age.
- Undergoing CABG surgery with the use of extracorporeal circulation.
- Willing and able to complete cognitive testing.
- Score < 16 on the Center for Epidemiological Studies in Depression scale (CES-D).
- Score > or = 28 on the Mini-Mental State Examination (MMSE).
Key exclusion criteria (16 listed)
- 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.
- History of stroke or other significant neurological disorder
- Transient ischemic attack (TIA) with ongoing cognitive sequelae
- Chronic atrial fibrillation or uncontrolled atrial fibrillation prior to surgery
- Myocardial infarction (MI) within the last 8 weeks and/or previous history of more than 3 MIs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AL-2081 dose of 300 mg | Drug | AL-208 |
| Placebo1 dose of placebo | Drug | Placebo |
Primary outcome
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
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.
3 secondary outcomes
The safety profile of AL-208 in subjects undergoing CABG surgery
Time frame: 14 days
The effect of treatment with AL-208 on postoperative personality changes in subjects undergoing CABG surgery
Time frame: 14 days
Concentration of AL-208 in plasma in subjects undergoing CABG surgery
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2012.
- Derived from this study: PubMed 41173865Gozes I, Blatt J, Guz LS. Systemic davunetide provides sex-specific neuroprotection during Coronary Artery Bypass Grafting (CABG). Transl Psychiatry. 2025 Oct 31;15(1):454. doi: 10.1038/s41398-025-03675-y.
Related trials for Mild Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Matthews, MD study director
Medical Monitor on behalf of Allon Therapeutics
28 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AL-208 in people with Mild Cognitive Impairment, run by Allon Therapeutics at 28 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00404014, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2012.