Alzheimer DiseasePhase 1NCT03418688
A Multiple Ascending Dose Study of COR388
A Phase 1 study testing COR388 in people with Alzheimer Disease, run by Cortexyme Inc. at 3 sites in United States.
Trial summary
The study is a randomized, double-blind, placebo-controlled, multiple ascending dose study to assess the safety and tolerability of ascending repeat doses of COR388 HCl in older healthy male and female subjects and a cohort of Alzheimer's disease subjects. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- COR388
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Mar 2018to 15 Oct 2018
- Phase
- Phase 1
- 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 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects ≥55 years to ≤80 years of age, at the time of consent;
- Males of reproductive potential must agree to use double-barrier contraceptive measures or avoid intercourse from the first dose of study drug through 90 days after the last dose of study drug.
- Females of child-bearing potential must be non-lactating, have negative serum pregnancy test results at Screening and negative urine pregnancy test results at Day -1; agree to use double-barrier or hormonal contraceptive measures or avoid intercourse from Day -10 through 28 days after the last dose of study drug.
- Stable doses of medications used for stable chronic illnesses that are not prohibited by the protocol are allowed as long as the dose has been stable for 30 days prior to Screening, and no changes are expected during participation in the study;
- Body mass index ≥19 kg/m2 to ≤35 kg/m2 at Screening;
- Good general health as determined by medical history, physical examination, laboratory reports, and 12-lead ECG prior to enrollment;
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- Non-smoker and non-tobacco user for a minimum of 6 months prior to the first admission and for the duration of the study;
- Able to swallow capsules;
- Fluent in, and able to read and comprehend, the English language;
- Cohort 4 Only:
- Must have probable AD according to the NINDS-ADRD criteria; and an MMSE-2 score ≥14 and ≤25;
- Must have moderate to severe periodontitis according to the CDC-AAP criteria as determined by the study dentist during the screening oral examination;
- If applicable, have a primary caregiver willing to accept responsibility for supervising the treatment (eg, administering study drug) and assessing the condition of the subject throughout the study in accordance with all protocol requirements.
- Provide, if mentally competent and willing, written informed consent. If the subject is not able to provide written informed consent, written informed consent must be obtained from a legally authorized representative on the subject's behalf, and verbal assent may be obtained from the subject. In addition, if the subject has a caregiver, the caregiver will be required to provide written informed consent prior to the subject's participation in the study.
Who cannot join
- History or current evidence of clinically significant arrhythmia, heart failure, or hypotension in the Investigator's judgment;
- History or current evidence of clinically significant liver disease in the Investigator's judgment;
- Evidence of renal insufficiency defined as an estimated glomerular filtration rate <50 mL/min/1.73m2 at Screening;
- Subjects who received any treatment for periodontitis in the last 90 days including systemic or local antibiotics (eg, PerioChip®), scaling, root planing, or other surgical treatments;
- Uncontrolled medical or psychiatric illness, uncontrolled seizure disorder, or history of major stroke;
- Active, or recent history of, systemic infection within 30 days prior to Screening that required treatment with antibiotics for longer than 1 week;
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- History or current evidence of psychiatric or emotional problems that would invalidate giving informed consent or limit the ability of the subject to comply with study requirements;
- History of systemic allergic reaction to any drug that is considered significant by the Investigator;
- History of alcohol or drug abuse or dependence within 12 months of Screening, as determined by the Investigator;
- Positive alcohol screen at Screening or on Day -1;
- Positive urine screen for prohibited drugs
- Positive blood screen for human immunodeficiency virus (1 and 2), hepatitis B surface antigen, or hepatitis C virus antibodies at Screening;
- Any conditions that, in the opinion of the Investigator, would make the subject unsuitable for enrollment, could interfere with the subject's participation in or completion of the study, or could interfere with interpretation of study results;
- Abnormal results of screening laboratory tests, ECG, or MRI of the brain deemed clinically significant by the Investigator;
- The use of any prohibited medication that cannot be stopped or replaced safely, based on the judgment of the Investigator; or
- Participation in another investigational new drug research study involving small molecule drugs within 30 days or biological drugs within 60 days prior to the first dose of study drug.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, 45227
Bioclinica Research
Orlando, Florida, 32806
Pacific Research Network
San Diego, California, 92103
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of COR388 in Older Healthy Volunteers and Patients With Alzheimer's Disease
The study is a randomized, double-blind, placebo-controlled, multiple ascending dose study to assess the safety and tolerability of ascending repeat doses of COR388 HCl in older healthy male and female subjects and a cohort of Alzheimer's disease subjects.
Read the detailed description
The study will enroll 3 cohorts of 8 healthy subjects ≥55 and ≤80 years of age at the Clinical Pharmacology Unit (CPU) and 1 cohort of 12 AD subjects ≥55 and ≤80 years of age. Subjects in cohorts 1-3 will receive the study drug or placebo for 10 consecutive days while confined to the CPU. AD patients in cohort 4 will receive the study drug or placebo for 28 days as outpatient. Blood samples samples will be collected for pharmacokinetic measurements.
- Conditions
- Alzheimer Disease
- Being tested
- COR388, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COR388Drug
Also called COR388 HCl
COR388 administered for 10 or 28 days.
PlaceboDrug
Placebo administered for 10 or 28 days.
| Study group | Role | What they receive |
|---|---|---|
| COR388 | Active comparator | Increasing doses of COR388 will be administered for 10 days in cohorts 1-3 and for 28 days in cohort 4. Receives: Drug: COR388 |
| Placebo | Placebo comparator | Matching placebo capsules will be administered for 10 days in cohorts 1-3 and for 28 days in cohort 4. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
Area under the concentration-time curve
Measured: Day 1 and Day 10
Cmax
Maximum observed drug concentration during a dosing interval
Measured: Day 1 and Day 10
Tmax
Time to Cmax
Measured: Day 1 and Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start6 Mar 2018
- Primary completion15 Oct 2018
- Study completion15 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cortexyme Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418688
- Sponsor's protocol ID
- COR388-002
- Status last verified
- Nov 2018
- First submitted
- 26 Jan 2018
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of COR388 in Older Healthy Volunteers and Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03418688
- Acronym / sponsor ID
- COR388-002
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Cortexyme Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 1 Feb 2018 (actual)
- 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 study is a randomized, double-blind, placebo-controlled, multiple ascending dose study to assess the safety and tolerability of ascending repeat doses of COR388 HCl in older healthy male and female subjects and a cohort of Alzheimer's disease subjects.
Detailed description
The study will enroll 3 cohorts of 8 healthy subjects ≥55 and ≤80 years of age at the Clinical Pharmacology Unit (CPU) and 1 cohort of 12 AD subjects ≥55 and ≤80 years of age. Subjects in cohorts 1-3 will receive the study drug or placebo for 10 consecutive days while confined to the CPU. AD patients in cohort 4 will receive the study drug or placebo for 28 days as outpatient. Blood samples samples will be collected for pharmacokinetic measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COR388 | Active comparator | Drug: COR388Increasing doses of COR388 will be administered for 10 days in cohorts 1-3 and for 28 days in cohort 4. |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo capsules will be administered for 10 days in cohorts 1-3 and for 28 days in cohort 4. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female subjects ≥55 years to ≤80 years of age, at the time of consent;
- Males of reproductive potential must agree to use double-barrier contraceptive measures or avoid intercourse from the first dose of study drug through 90 days after the last dose of study drug.
- Females of child-bearing potential must be non-lactating, have negative serum pregnancy test results at Screening and negative urine pregnancy test results at Day -1; agree to use double-barrier or hormonal contraceptive measures or avoid intercourse from Day -10 through 28 days after the last dose of study drug.
- Stable doses of medications used for stable chronic illnesses that are not prohibited by the protocol are allowed as long as the dose has been stable for 30 days prior to Screening, and no changes are expected during participation in the study;
- Body mass index ≥19 kg/m2 to ≤35 kg/m2 at Screening;
Key exclusion criteria (16 listed)
- History or current evidence of clinically significant arrhythmia, heart failure, or hypotension in the Investigator's judgment;
- History or current evidence of clinically significant liver disease in the Investigator's judgment;
- Evidence of renal insufficiency defined as an estimated glomerular filtration rate <50 mL/min/1.73m2 at Screening;
- Subjects who received any treatment for periodontitis in the last 90 days including systemic or local antibiotics (eg, PerioChip®), scaling, root planing, or other surgical treatments;
- Uncontrolled medical or psychiatric illness, uncontrolled seizure disorder, or history of major stroke;
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 |
|---|---|---|
| COR388Also: COR388 HClCOR388 administered for 10 or 28 days. | Drug | COR388 |
| PlaceboPlacebo administered for 10 or 28 days. | Drug | Placebo |
Primary outcome
AUC
Time frame: Day 1 and Day 10
Area under the concentration-time curve
Cmax
Time frame: Day 1 and Day 10
Maximum observed drug concentration during a dosing interval
Tmax
Time frame: Day 1 and Day 10
Time to Cmax
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 7 Nov 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing COR388 in people with Alzheimer Disease, run by Cortexyme Inc. at 3 sites in United States.
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 14 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 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
AUC (time frame: Day 1 and Day 10). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2018.