Alzheimer DiseasePhase 2ElevageNCT03980730
Study of Azeliragon in Patients With Mild Alzheimer's Disease and Impaired Glucose Tolerance
A Phase 2 study testing Azeliragon in people with Alzheimer Disease, run by vTv Therapeutics at 33 sites in 2 countries.
Trial summary
This is a study to evaluate the efficacy and safety of azeliragon in patients with mild Alzheimer's disease and impaired glucose tolerance. Patients will receive either azeliragon or placebo with a patient's participation lasting approximately 9 months (in Part 1) or 21 months (in Part 2). Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Azeliragon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 33 sitesin 2 countries
- Study dates
- 27 Jun 2019to 29 Jan 2021
- Phase
- Phase 2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of probable Alzheimer Disease (AD) with documented evidence of progression of disease
- Mini Mental State Examination (MMSE) score of 21-26, inclusive
- Clinical Dementia Rating global score of 0.5 or 1
- Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog14) of 10 or more
- Brain magnetic resonance imaging (MRI) consistent with the diagnosis of probable AD
- Concurrent use of cholinesterase inhibitor or memantine with stable dose for at least 2 months prior to screening
Show all 9Show fewer
- Hemoglobin A1c (HbA1c) 6.5% - 9.5%, inclusive
- Caregiver willing to participate and be able to attend clinic visits with patient
- Ability to ingest oral medications
Who cannot join
- Significant neurological or psychiatric disease other than Alzheimer's disease
- Previous clinical trial participation within 90 days of screening
- Previous exposure to putative disease modifying therapy for Alzheimer's disease within 1 year of screening
- History of cancer within the last 5 years except adequately treated cervical carcinoma in-situ, cutaneous basal cell or squamous cell cancer, or non-progressive prostate cancer not requiring current treatment
- Women of childbearing potential
- Uncontrolled blood pressure and/or blood pressure above 140/90
Show all 11Show fewer
- Participants receiving medications that may negatively impact cognitive function
- History of diabetic ketoacidosis within the past year
- History of chronic pancreatitis
- Stage 4 kidney disease
- Use of insulin therapy
Trial locations and contacts
33 sites in 2 countries.
33 sites in 2 countries
United States27 sites
Emory Alzheimer's Clinical Research Unit
Atlanta, Georgia, 30329
JEM Research Institute
Atlantis, Florida, 33462
ANI Neurology dba Alzheimer's Memory Center
Charlotte, North Carolina, 28270
The Ohio State University
Columbus, Ohio, 43210
NeuroStudies.net LLC
Decatur, Georgia, 30033
Brain Matters Research
Delray Beach, Florida, 33445
Clarity Clinical Research
East Syracuse, New York, 13057
Memory Center / Hattiesburg Clinic
Hattiesburg, Mississippi, 39401
IU Health Partners, Adult Neurology Clinic
Indianapolis, Indiana, 46202
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Charter Research
Lady Lake, Florida, 32159
Neurological Associates of Long Island
Lake Success, New York, 11042
Alzheimer's Research and Treatment Center
Lake Worth, Florida, 33449
ClinCloud
Maitland, Florida, 32751
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510
Synexus Clinical Research US
Orlando, Florida, 32806
Emerald Coast Center for Neurological Disorders
Pensacola, Florida, 32514
Progressive Medical Research
Port Orange, Florida, 32127
Summit Research Network
Portland, Oregon, 97210
Center for Cognitive Health
Portland, Oregon, 97225
Raleigh Neurology Associates
Raleigh, North Carolina, 27607
The Roskamp Institute
Sarasota, Florida, 34243
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, 07081
Millennium Psychiatric Associates
St Louis, Missouri, 63132
Brain Matters Research
Stuart, Florida, 34997
Tucson Neuroscience Research
Tucson, Arizona, 85710
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
Canada6 sites
Recherches Neuro-Hippocampe Inc.
Gatineau, Quebec, J8T 8J1
True North Clinical Research Inc.
Halifax, Nova Scotia, B3S 1M7
Okanagan Clinical Trials Ltd.
Kelowna, British Columbia, V1Y 1Z9
True North Clinical Research Inc.
Kentville, Nova Scotia, B4N 4K9
Recherches Neuro-Hippocampe
Ottawa, Ontario, K1Z IG3
Q&T Research Sherbrooke Inc
Sherbrooke, Quebec, J1J 2G2
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Multicenter Studies to Evaluate the Safety and Efficacy of Azeliragon as a Treatment for Subjects With Mild Alzheimer's Disease and Impaired Glucose Tolerance
This is a study to evaluate the efficacy and safety of azeliragon in patients with mild Alzheimer's disease and impaired glucose tolerance. Patients will receive either azeliragon or placebo with a patient's participation lasting approximately 9 months (in Part 1) or 21 months (in Part 2).
- Conditions
- Alzheimer Disease
- Being tested
- Azeliragon, Placebo
- Keywords
- Receptor for Advanced Glycation Endproducts (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.
AzeliragonDrug
Also called TTP488
Azeliragon 5 mg capsule administered orally, once daily
PlaceboDrug
Matching placebo capsule administered orally, once daily
| Study group | Role | What they receive |
|---|---|---|
| Azeliragon | Experimental | Azeliragon 5mg capsule administered orally, once daily for 6 months (Part 1) or 18 months (Part 2) Receives: Drug: Azeliragon |
| Placebo | Placebo comparator | Matching placebo capsule administered orally, once daily for 6 months (Part 1) or 18 months (Part 2) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 : Change From Baseline in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog14) at Month 6
The Alzheimer's Disease Assessment Scale - Cognitive Subscale 14 Item (ADAS-cog14) scoring range is from 0 to 90, with higher scores indicating greater cognitive impairment
Measured: Baseline to Month 6
Secondary outcomes (4)
Part 1: Change From Baseline in the Amsterdam-Instrumental Activities of Daily Living (Amsterdam-IADL) at Month 6
The Amsterdam-Instrumental Activities of Daily Living score is calculated from a questionnaire consisting of 70 items in seven categories using an item response theory method of scoring. Scores range from 20 to 80 where lower scores indicate greater functional impairment.
Measured: Baseline to Month 6
Part 1: Change From Baseline in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-sb) at Month 6
Clinical Dementia Rating - Sum of box (CDR-sb) scores range from 0 to 18 with higher scores indicating greater cognitive impairment.
Measured: Baseline to Month 6
Part 1: Change From Baseline in the Functional Activities Questionnaire (FAQ) at Month 6
The total FAQ score ranges from 0 to 30, with higher scores indicating greater functional loss.
Measured: Baseline to Month 6
Mean Change From Baseline in the Mini Mental State Exam (MMSE) at Month 6.
The MMSE scale range is 0 to 30 with lower scores indicating greater cognitive impairment.
Measured: Baseline to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start27 Jun 2019
- Primary completion1 Dec 2020
- Study completion29 Jan 2021
Why it stopped: for business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- vTv Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980730
- Sponsor's protocol ID
- TTP488-305
- Acronym
- Elevage
- Status last verified
- Dec 2021
- First submitted
- 31 May 2019
- Last updated
- 21 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Multicenter Studies to Evaluate the Safety and Efficacy of Azeliragon as a Treatment for Subjects With Mild Alzheimer's Disease and Impaired Glucose Tolerance
- ClinicalTrials.gov ID
- NCT03980730
- Acronym / sponsor ID
- Elevage / TTP488-305
- Conditions
- Alzheimer Disease
- Keywords
- Receptor for Advanced Glycation Endproducts (RAGE), ADAS-cog, CDR-sb
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: for business reasons
- Enrolment
- 43 participants (actual)
- Lead sponsor
- vTv TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 29 Jan 2021 (actual)
- First posted
- 10 Jun 2019 (actual)
- Results
- Posted 21 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to evaluate the efficacy and safety of azeliragon in patients with mild Alzheimer's disease and impaired glucose tolerance. Patients will receive either azeliragon or placebo with a patient's participation lasting approximately 9 months (in Part 1) or 21 months (in Part 2).
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 |
|---|---|---|
| Azeliragon | Experimental | Drug: AzeliragonAzeliragon 5mg capsule administered orally, once daily for 6 months (Part 1) or 18 months (Part 2) |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo capsule administered orally, once daily for 6 months (Part 1) or 18 months (Part 2) |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of probable Alzheimer Disease (AD) with documented evidence of progression of disease
- Mini Mental State Examination (MMSE) score of 21-26, inclusive
- Clinical Dementia Rating global score of 0.5 or 1
- Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog14) of 10 or more
- Brain magnetic resonance imaging (MRI) consistent with the diagnosis of probable AD
Key exclusion criteria (11 listed)
- Significant neurological or psychiatric disease other than Alzheimer's disease
- Previous clinical trial participation within 90 days of screening
- Previous exposure to putative disease modifying therapy for Alzheimer's disease within 1 year of screening
- History of cancer within the last 5 years except adequately treated cervical carcinoma in-situ, cutaneous basal cell or squamous cell cancer, or non-progressive prostate cancer not requiring current treatment
- Women of childbearing potential
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 |
|---|---|---|
| AzeliragonAlso: TTP488Azeliragon 5 mg capsule administered orally, once daily | Drug | Azeliragon |
| PlaceboMatching placebo capsule administered orally, once daily | Drug | Placebo |
Primary outcome
Part 1 : Change From Baseline in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog14) at Month 6
Time frame: Baseline to Month 6
The Alzheimer's Disease Assessment Scale - Cognitive Subscale 14 Item (ADAS-cog14) scoring range is from 0 to 90, with higher scores indicating greater cognitive impairment
4 secondary outcomes
Part 1: Change From Baseline in the Amsterdam-Instrumental Activities of Daily Living (Amsterdam-IADL) at Month 6
Time frame: Baseline to Month 6
Part 1: Change From Baseline in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-sb) at Month 6
Time frame: Baseline to Month 6
Part 1: Change From Baseline in the Functional Activities Questionnaire (FAQ) at Month 6
Time frame: Baseline to Month 6
Mean Change From Baseline in the Mini Mental State Exam (MMSE) at Month 6.
Time frame: Baseline to Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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.
33 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 Azeliragon in people with Alzheimer Disease, run by vTv Therapeutics at 33 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 9 inclusion and 11 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 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 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?
Yes. Results are posted in the registry (first posted 21 Jan 2022). 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?
Part 1 : Change From Baseline in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog14) at Month 6 (time frame: Baseline to Month 6). 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 21 Jan 2022.