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Alzheimer's DiseasePhase 1NCT02386306

Study Evaluating Safety, Tolerability, and PK of Multiple Ascending Doses of GC021109 in Subjects With Mild to Moderate Alzheimer's Disease

A Phase 1 study testing GC021109 in people with Alzheimer's Disease, run by GliaCure, Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 1b, multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetics of GC021109 in subjects with mild to moderate Alzheimer's Disease (as determined by 2011 National Institute on Aging- Alzheimer's Association [NIA-AA] criteria and… Read more about this study

Who is it for?
Ages 55 to 85 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
GC021109
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
39 participants
Where
5 sitesUnited States
Study dates
Feb 2015to Oct 2015
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects aged 55-85 years, inclusive, at the time of informed consent.
  • Subjects diagnosed with mild to moderate AD as determined by the following:
  • Diagnosis of probable AD according to the 2011 NIA-AA criteria
  • MMSE (using serial 7's) score of 12-26 at screening (Mild defined as 20-26 and Moderate defined as 12-19)
  • Documentation in the clinic notes of mild/moderate AD
  • If on AD therapy, stable dose for at least 3 months prior to screening.
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  • All male subjects must practice effective contraception during the study. Females of childbearing potential must use a medically accepted form of birth control, unless postmenopausal for > 1 year (as documented by elevated follicle-stimulating hormone [FSH]) or surgically sterile. All females of childbearing potential must have a negative serum pregnancy test (human chorionic gonadotropin beta [hCGβ]) at screening and a negative urine pregnancy test on Day 1 pre-dose.
  • Body mass index (BMI) between 18 and 35 kg/m2, inclusive, at screening.
  • Must have an eligible caregiver (who spends a minimum of 10 hours per week with the subject) who will be available for the duration of the study to serve as the subject's designee. Caregiver must be willing to comply with study procedures.
  • Caregiver must sign a caregiver ICF after the nature and risks of study participation have been fully explained to them.
  • Patients who are capable, according to the Investigator, or patient's legally authorized representative, must sign a patient ICF after the nature and risks of study participation have been fully explained to them.
  • Patients who are capable of providing assent but not capable of signing the ICF, according to the Investigator, should provide assent for study participation.
  • Patients who sign the ICF are not required to provide a separate assent.
  • Patients who are not capable of providing assent are still allowed to participate provided the patient's legally authorized representative agrees to participation.
  • Investigators must document the reasons for any patient that is unable to provide assent and maintain this documentation with the consent/assent documents.
  • Must be able to comply with all study requirements and restrictions for the duration of the study.
  • Non-smoker and non-tobacco user for a minimum of 3 months prior to screening and for the duration of the study.
  • Ability to swallow capsules.

Who cannot join

  • MRI findings inconsistent with AD within the previous 12 months. All subjects must have had a MRI within the previous 12 months to be eligible.
  • History or current evidence of any clinically significant cardiac, endocrinologic, hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator.
  • History of cancer within the past five years (excluding non-melanoma skin cancer).
  • Active suicidal ideation reported on the Columbia - Suicide Severity Rating Scale (C SSRS) at screening.
  • Clinically significant abnormal laboratory test values at screening (as determined by the Investigator), including:
  • any values for alanine aminotransferase (ALT) or aspartate aminotransferase (AST) that are 1.5 times above the upper limit of the reference range
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  • any values for total or direct bilirubin that are 1.5 times above the upper limit of the reference range
  • estimated glomerular filtration rate <85ml/min/1.73m2.
  • Subjects with a QTc of ≥450 msec for males and ≥470 msec for females at screening.
  • Participation in another clinical trial or treatment with an investigational agent within 30 days or 5 half-lives, whichever is longer, prior to Day 1.
  • Subjects with a body weight > 120 kg at screening.
  • History of alcohol or drug abuse or dependence within 12 months of screening as determined by the Investigator.
  • Clinically significant infection within 3 months of screening as determined by the Investigator.
  • Any conditions that, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject's participation in or completion of the study.
  • Positive urine screen for prohibited drugs (cocaine, cannabinoids, nicotine [urine cotinine is the detection mechanism for nicotine], opiates, barbiturates, amphetamines, and benzodiazepines) or positive alcohol Breathalyzer on Day 1.
  • Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCVAb) at screening.
  • Known or suspected hypersensitivity or idiosyncratic reaction to study medication or any components thereof.
  • Has donated blood within 3 months of screening or plans to donate blood within 3 months of study completion.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Quantum laboratories / Memory Disorder Center

    Deerfield Beach, Florida, 33064

  • MD Clinical

    Hallandale, Florida, 33009

  • Alzheimer's Research and Treatment Center

    Lake Worth, Florida, 33449

  • Collaborative Neuroscience Network

    Long Beach, California, 90806

  • Compass Research

    Orlando, Florida, 32806

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled; Phase 1b, Safety, Tolerability, and Pharmacokinetic Study of Multiple Ascending Doses of GC021109 in Subjects With Mild to Moderate Alzheimer's Disease

This is a Phase 1b, multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetics of GC021109 in subjects with mild to moderate Alzheimer's Disease (as determined by 2011 National Institute on Aging- Alzheimer's Association [NIA-AA] criteria and Mini Mental State Examination [MMSE]). The Investigator, study site staff, (with exception of a designated pharmacist/pharmacy technician) and all study subjects will be blinded to randomized study medication assignment until database lock. Treatment assignments may be unblinded for select pre-authorized individuals involved in the safety and PK data reviews in order to accurately determine how to proceed with dose escalation.

Being tested
GC021109, 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.

  • GC021109Drug

  • PlaceboOther

Study groups in NCT02386306
Study groupRoleWhat they receive
Treatment Cohort 1ExperimentalEach study participant will be administered with one 1mg dose capsule per day of GC021109 for 28 days.
Receives: Drug: GC021109
Placebo Cohort 1Placebo comparatorPatients receiving placebo as part of each cohort will be dosed with a comparable capsule to those in the treatment arm of each cohort.
Receives: Other: Placebo
Treatment Cohort 2ExperimentalEach study participant will be administered with one dose per day of GC021109 for 28 days. Dose levels will be determined following a review of cohort 1 safety data through day 14
Receives: Drug: GC021109
Placebo Cohort 2Placebo comparatorPatients receiving placebo as part of each cohort will be dosed with a comparable capsule to those in the treatment arm of each cohort.
Receives: Other: Placebo
Treatment Cohort 3ExperimentalEach study participant will be administered with one dose per day of GC021109 for 28 days. Dose levels will be determined following a review of cohort 2 safety data through day 14
Receives: Drug: GC021109
Placebo Cohort 3Placebo comparatorPatients receiving placebo as part of each cohort will be dosed with a comparable capsule to those in the treatment arm of each cohort.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of the number and severity of treatment-emergent AEs (TEAEs) following single oral doses of GC021109 and placebo from Day 1 through Day 28

    Measured: 28 days

Secondary outcomes (2)

  1. Estimate of the pharmacokinetic (PK) parameters of multiple, escalating dose levels of GC021109: AUC0-t, AUC0-24, AUC0-inf, AUC%extrap, CL/F, Cmax, Tmax, λz, and t1/2.

    Change in plasma PK concentrations will be measured pre-dose through Day 28 of the study and PK parameters derived using non-compartmental and/or compartmental methods as appropriate. The following PK parameters of GC021109 will be calculated: AUC0-t, AUC0-24, AUC0-inf, AUC%extrap, CL/F, Cmax, Tmax, λz, and t1/2.

    Measured: 28 days

  2. Determine the effect of multiple, escalating dose levels of GC021109 on potential biomarkers of activities.

    Plasma and cerebrospinal fluid samples will be collected pre-dose and on Day 28 to analyze biomarkers such as IL-12, amyloid β, and tau.

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionOct 2015
  4. Study completionOct 2015

Resources

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
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02386306
Sponsor's protocol ID
GC-100-02
Status last verified
Jul 2015
First submitted
16 Feb 2015
Last updated
3 Feb 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GC021109 in people with Alzheimer's Disease, run by GliaCure, Inc. at 5 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 18 inclusion and 18 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 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

Assessment of the number and severity of treatment-emergent AEs (TEAEs) following single oral doses of GC021109 and placebo from Day 1 through Day 28 (time frame: 28 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 NCT02386306.

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 3 Feb 2016.

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