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Alzheimer's DiseasePhase 3NCT02916056

2-Year Extension Study of Azeliragon in Subjects With Alzheimer's Disease (STEADFAST Extension)

A Phase 3 study testing Azeliragon 5mg in people with Alzheimer's Disease, run by vTv Therapeutics at 71 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is an open-label extension study in patients with mild Alzheimer's disease who have completed participation in the azeliragon Phase 3 (STEADFAST) trial. Patients will receive azeliragon 5 mg/day for up to 2 years. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Alzheimer's Disease
What is being tested?
Azeliragon 5mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
297 participants
Where
71 sitesin 2 countries
Study dates
Dec 2016to 1 Jun 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Successful completion of Study TTP488-301 through the Month 18 Visit without ongoing serious adverse events or history of serious adverse drug reactions during study TTP488-301.
  • Patients must enroll in the present study within 7 days of completion of study TTP488-301.
  • Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally authorized representative) and caregiver/informant has been informed of all pertinent aspects of the study. Participants must be able to provide assent (where this is in accordance with local laws, regulations and ethics committee policy) and assent may be re-evaluated during the study at regular intervals.
  • Participants and caregiver/informants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • The subject must have a reliable caregiver/informant with regular contact (i.e., 10 hours a week as combination of face-to-face visits and telephone contact acceptable) who will facilitate the subject's full participation in the study. Caregivers/informant must have sufficient subject interaction to be able to provide meaningful input into the rating scales administered in this study where caregiver/informant input is required, in particular the CDR and evidence of this should be documented in source documentation. Participants who reside in assisted living facilities are permitted provided that they meet caregiver/informant criteria.
  • Participants and caregiver/informants must be able to read, write, and speak the language in which psychometric tests are provided with visual and auditory acuity (corrected) sufficient to allow for accurate psychometric testing.
  • Subject must be able to ingest oral medications.

Who cannot join

  • The subject is felt by the investigator to be unsuitable (on the basis of health, compliance, caregiver availability, or for any other reason) for inclusion in the study.
  • Subjects with serious suicide risk. If there are "yes" answers on items 4, 5 or on any behavioral question of the C-SSRS, a suicide risk assessment must be done by a qualified mental health professional with expertise in the evaluation of suicidality in the elderly (e.g., psychiatrist, geriatrician or neurologist specializing in treatment of patients with AD) to determine whether it is safe for the subject to participate in the study.
  • Subjects demonstrating a QTcF > 480 msec or a >45 msec change from the TTP488-301 Baseline value based on the locally read ECG performed at the TTP488-301 Month 18 Visit (TTP488-303 Baseline). Participants with known history of bundle branch block (either right or left) are allowed if absolute QTcF value does not exceed 500 msec. Participants with a functioning pacemaker, indicated by an ECG displaying paced rhythm, are allowed with no QTc upper limit.
  • Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may prevent the subject from completing the 2-year study or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.

Trial locations and contacts

71 sites in 2 countries.

71 sites in 2 countries

United States65 sites

  • Study site

    Albany, New York, 12208

  • Study site

    Albuquerque, New Mexico, 87109

  • Study site

    Atlantis, Florida, 33462

  • Study site

    Baltimore, Maryland, 21208

  • Study site

    Bellflower, California, 90706

  • Study site

    Canton, Ohio, 44718

  • Study site

    Charlotte, North Carolina, 28270

  • Study site

    Chicago, Illinois, 60640

  • Study site

    Columbus, Georgia, 31909

  • Study site

    Cordova, Tennessee, 38018

  • Study site

    Costa Mesa, California, 92626

  • Study site

    Creve Coeur, Missouri, 63141

  • Study site

    Dallas, Texas, 75231

  • Study site

    Delray Beach, Florida, 33445

  • Study site

    East Providence, Rhode Island, 02914

  • Study site

    East Providence, Rhode Island, 02916

  • Study site

    Fairway, Kansas, 66205

  • Study site

    Fullerton, California, 92835

  • Study site

    Glendale, California, 91206

  • Study site

    Hallandale, Florida, 33009

  • Study site

    Hattiesburg, Mississippi, 39401

  • Study site

    Hialeah, Florida, 33016

  • Study site

    Imperial, California, 92251

  • Study site

    Irvine, California, 92614

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Kirkland, Washington, 98033

  • Study site

    Laguna Hills, California, 92653

  • Study site

    Lake Success, New York, 11042

  • Study site

    Lake Worth, Florida, 33449

  • Study site

    Lexington, Kentucky, 40504

  • Study site

    Long Beach, California, 90806

  • Study site

    Miami, Florida, 33122

  • Study site

    Miami, Florida, 33137

  • Study site

    Miami Beach, Florida, 33140

  • Study site

    Miami Lakes, Florida, 33014

  • Study site

    Murray, Utah, 84123

  • Study site

    New York, New York, 10032

  • Study site

    Newton, Massachusetts, 02459

  • Study site

    Oklahoma City, Oklahoma, 73103

  • Study site

    Oklahoma City, Oklahoma, 73118

  • Study site

    Orlando, Florida, 32806

  • Study site

    Phoenix, Arizona, 85004

  • Study site

    Phoenix, Arizona, 85013

  • Study site

    Plains, Pennsylvania, 18705

  • Study site

    Plymouth, Massachusetts, 02360

  • Study site

    Portland, Oregon, 97210

  • Study site

    Portland, Oregon, 97225

  • Study site

    Princeton, New Jersey, 08540

  • Study site

    Quincy, Massachusetts, 02169

  • Study site

    Raleigh, North Carolina, 27607

  • Study site

    Riverside, California, 92506

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Antonio, Texas, 78232

  • Study site

    San Bernardino, California, 92408

  • Study site

    Santa Ana, California, 92705

  • Study site

    Sarasota, Florida, 34243

  • Study site

    Shaker Heights, Ohio, 44122

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Staten Island, New York, 10312

  • Study site

    Sunrise, Florida, 33351

  • Study site

    The Villages, Florida, 32162

  • Study site

    Tucson, Arizona, 85724

  • Study site

    Wichita Falls, Texas, 76309

  • Study site

    Wilmington, North Carolina, 28401

  • Study site

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada6 sites

  • Study site

    Calgary, Alberta, T2N 4Z6

  • Study site

    Chatham, Ontario, N7L 1C1

  • Study site

    Gatineau, Quebec, J8T 8J1

  • Study site

    Greenfield Park, Quebec, J4V 2J2

  • Study site

    Medicine Hat, Alberta, T1B 4E7

  • Study site

    Toronto, Ontario, M3B 2S7

Other trials in Canada

About this study

Official title: Open Label Extension Study for Continued Safety and Efficacy Evaluation of Azeliragon in Patients With Mild Alzheimer's Disease

This is an open-label extension study in patients with mild Alzheimer's disease who have completed participation in the azeliragon Phase 3 (STEADFAST) trial. Patients will receive azeliragon 5 mg/day for up to 2 years.

Being tested
Azeliragon 5mg
Keywords
Alzheimer's disease, RAGE, ADAS-cog, CDR-sb
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Azeliragon 5mgDrug

    Also called TTP488

Study groups in NCT02916056
Study groupRoleWhat they receive
Azeliragon 5 mgExperimentalAzeliragon (TTP488) 5mg orally once daily for 2 years
Receives: Drug: Azeliragon 5mg

What is being measured

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

  1. Number of Subjects With at Least One Treatment-Emergent Adverse Event

    Measured: up to 18 months

Timeline

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

  1. First posted27 Sep 2016 (estimated)
  2. Study startDec 2016
  3. Primary completion1 Jun 2018
  4. Study completion1 Jun 2018

Why it stopped: Not due to safety but due to a lack of efficacy at the 5 mg azeliragon dose.

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
297 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02916056
Sponsor's protocol ID
TTP488-303
Status last verified
May 2021
First submitted
10 Aug 2016
Last updated
1 Jun 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Azeliragon 5mg in people with Alzheimer's Disease, run by vTv Therapeutics at 71 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 4 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: stopped early, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Subjects With at Least One Treatment-Emergent Adverse Event (time frame: up to 18 months). 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 NCT02916056.

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 1 Jun 2021.

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Clinical Trial NCT02916056 | AzTrials