Alzheimer DiseasePhase 2ACT-ADNCT04491006
A Study of ATH-1017 in Mild to Moderate Alzheimer's Disease
A Phase 2 study testing ATH-1017 in people with Alzheimer Disease and Dementia of Alzheimer Type, run by LeonaBio at 13 sites in 2 countries.
Trial summary
This study is designed to evaluate treatment effects of ATH-1017 (fosgonimeton) in mild to moderate Alzheimer's subjects with a randomized treatment duration of 26-weeks. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer Disease, Dementia of Alzheimer Type
- What is being tested?
- ATH-1017
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 23 Nov 2020to 20 May 2022
- 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 55 to 85 years
- Mild-to-moderate AD dementia subjects, MMSE 14-24, CDR 1 or 2 at Screening
- Clinical diagnosis of dementia, due probably to AD, by Revised National Institute on Aging-Alzheimer's Association criteria (McKhann, 2011)
- Reliable and capable support person/caregiver
- Treatment-free or receiving stable acetylcholinesterase inhibitor (AChEI) treatment, defined as:
- Treatment-naïve, OR
- Subjects are on a stable, approved dose of an AChEI (except for donepezil at 23 mg PO) for at least 3 months before Screening OR
- Subjects who received an AChEI in the past and discontinued 4 weeks prior to Screening
Who cannot join
- History of significant neurologic disease, other than AD, that may affect cognition, or concurrent with the onset of dementia
- History of unexplained loss of consciousness, and epileptic fits (unless febrile)
- Subject has atypical variant presentation of AD, if known from medical history, particularly non-amnestic AD
- History of brain MRI scan indicative of any other significant abnormality
- Hearing test result considered unacceptable for auditory ERP P300 assessment
- Diagnosis of severe major depressive disorder even without psychotic features
Show all 18Show fewer
- Significant suicide risk
- History within 2 years of Screening, or current diagnosis of psychosis
- Myocardial infarction or unstable angina within the last 6 months
- Clinically significant (in the judgment of the investigator) cardiac arrhythmia (including atrial fibrillation), cardiomyopathy, or cardiac conduction defect (note: pacemaker is acceptable)
- Subject has either hypertension (supine diastolic blood pressure > 95 mmHg), or symptomatic hypotension in the judgment of the investigator
- Clinically significant ECG abnormality at Screening
- Renal insufficiency (serum creatinine > 2.0 mg/dL)
- Hepatic impairment with alanine aminotransferase or aspartate aminotransferase > 2 times the upper limit of normal, or Child-Pugh class B and C
- Malignant tumor within 3 years before Screening
- Memantine in any form, combination or dosage within 4 weeks prior to Screening
- Donepezil at 23 mg PO
- The subject has received active amyloid or tau immunization (i.e., vaccination for Alzheimer's disease) at any time, or passive immunization (i.e., monoclonal antibodies for Alzheimer's disease) within 6 months of Screening
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States7 sites
Neurological Associates of Albany
Albany, New York, 12208
iResearch Atlanta
Decatur, Georgia, 30030
Evergreen Health Research Program
Kirkland, Washington, 98034
Center for Cognitive Health
Portland, Oregon, 97225
Syrentis Clinical Research
Santa Ana, California, 92705
University of Washington
Seattle, Washington, 98104
Premiere Research Institute
West Palm Beach, Florida, 33407
Australia6 sites
Central Coast Neurosciences Research
Central Coast, New South Wales, 2261
St Vincent's Centre for Applied Medical Research, Translational Research Centre
Darlinghurst, New South Wales, 2010
Hammondcare Greenwich Hospital
Greenwich, New South Wales, 2065
KaRa MINDS
Macquarie Park, New South Wales, 2113
HammondCare
Malvern, Victoria, 3144
Australian Alzheimer's Research Organization
Nedlands, Western Australia, 6009
About this study
Official title: A Randomized, Placebo-Controlled, Translational Study of ATH-1017 in Subjects With Mild to Moderate Alzheimer's Disease
This study is designed to evaluate treatment effects of ATH-1017 (fosgonimeton) in mild to moderate Alzheimer's subjects with a randomized treatment duration of 26-weeks.
Read the detailed description
This study is designed to assess the correlation of the functional translational biomarker P300 latency and change in ADAS-Cog11 induced by ATH-1017 therapy, over 26-week randomized, double-blind treatment.
- Conditions
- Alzheimer Disease, Dementia of Alzheimer Type
- Being tested
- ATH-1017, Placebo
- Keywords
- Alzheimer's Disease, Cognition, Dementia, ATH-1017, Memory Loss
- Medical subject headings
- Alzheimer Disease, Dementia, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATH-1017Drug
Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe
PlaceboDrug
Daily subcutaneous (SC) injection of Placebo in a pre-filled syringe
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | Daily subcutaneous (SC) injection of Low Dose ATH-1017 Receives: Drug: ATH-1017 |
| High Dose | Experimental | Daily subcutaneous (SC) injection of High Dose ATH-1017 Receives: Drug: ATH-1017 |
| Placebo | Placebo comparator | Daily subcutaneous (SC) injection of Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-related Potential (ERP) P300 Latency at Baseline
ERP P300 was a method of recording brain activity elicited by external stimuli, for example (e.g.), an oddball auditory stimulus, particularly of working memory access. The participant had to perform a task related to auditory stimuli in order to assess the P300 component (latency). The stimulus consisted of an oddball paradigm with 2 sound stimuli. Stimuli were presented through headphones and auditory stimulation for P300 was assessed in a recording lasting up to 10 minutes. It was calculated as the average across the pre-dose values at Baseline visit. Baseline was defined as Day 1.
Measured: At Baseline (Day 1)
Secondary outcomes (1)
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at Baseline
The ADAS-Cog11 was designed to measure cognitive symptom change in participants with Alzheimer's Disease (AD) and consisted of 11 tasks. It was performed to evaluate the correlation of ERP P300 latency and cognition. The standard 11 items (and corresponding score range) were: word recall (0-10), commands (0-5), constructional praxis (0-5), naming objects and fingers (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), spoken language ability (0-5), comprehension of spoken language (0-5), word-finding difficulty (0-5), and remembering test instructions (0-5). The test included 7 performance items and 4 clinician-rated items. The ADAS-Cog11 total score was the sum of all 11 individual items, with a total score ranging from 0 (no impairment) to 70 (severe impairment). Higher scores indicated more severe cognitive impairment. Baseline was defined as Day 1.
Measured: At Baseline (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start23 Nov 2020
- Primary completion20 May 2022
- Study completion20 May 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- Randomized, double-blind, placebo-controlled, parallel-group study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- LeonaBio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491006
- Sponsor's protocol ID
- ATH-1017-AD-0202
- Other IDs
- U1111-1255-9714, 18PTC-R-589358, 1R01AG068268-01
- Acronym
- ACT-AD
- Status last verified
- May 2023
- First submitted
- 23 Jul 2020
- Last updated
- 12 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21.
PubMed 21514250
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Translational Study of ATH-1017 in Subjects With Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04491006
- Acronym / sponsor ID
- ACT-AD / ATH-1017-AD-0202
- Conditions
- Alzheimer Disease, Dementia of Alzheimer Type
- Keywords
- Alzheimer's Disease, Cognition, Dementia, ATH-1017, Memory Loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- LeonaBioIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 29 Jul 2020 (actual)
- Results
- Posted 12 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate treatment effects of ATH-1017 (fosgonimeton) in mild to moderate Alzheimer's subjects with a randomized treatment duration of 26-weeks.
Detailed description
This study is designed to assess the correlation of the functional translational biomarker P300 latency and change in ADAS-Cog11 induced by ATH-1017 therapy, over 26-week randomized, double-blind treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, double-blind, placebo-controlled, parallel-group study
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Experimental | Drug: ATH-1017Daily subcutaneous (SC) injection of Low Dose ATH-1017 |
| High Dose | Experimental | Drug: ATH-1017Daily subcutaneous (SC) injection of High Dose ATH-1017 |
| Placebo | Placebo comparator | Drug: PlaceboDaily subcutaneous (SC) injection of Placebo |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 55 to 85 years
- Mild-to-moderate AD dementia subjects, MMSE 14-24, CDR 1 or 2 at Screening
- Clinical diagnosis of dementia, due probably to AD, by Revised National Institute on Aging-Alzheimer's Association criteria (McKhann, 2011)
- Reliable and capable support person/caregiver
- Treatment-free or receiving stable acetylcholinesterase inhibitor (AChEI) treatment, defined as:
Key exclusion criteria (18 listed)
- History of significant neurologic disease, other than AD, that may affect cognition, or concurrent with the onset of dementia
- History of unexplained loss of consciousness, and epileptic fits (unless febrile)
- Subject has atypical variant presentation of AD, if known from medical history, particularly non-amnestic AD
- History of brain MRI scan indicative of any other significant abnormality
- Hearing test result considered unacceptable for auditory ERP P300 assessment
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 |
|---|---|---|
| ATH-1017Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe | Drug | High Dose, Low Dose |
| PlaceboDaily subcutaneous (SC) injection of Placebo in a pre-filled syringe | Drug | Placebo |
Primary outcome
Event-related Potential (ERP) P300 Latency at Baseline
Time frame: At Baseline (Day 1)
ERP P300 was a method of recording brain activity elicited by external stimuli, for example (e.g.), an oddball auditory stimulus, particularly of working memory access. The participant had to perform a task related to auditory stimuli in order to assess the P300 component (latency). The stimulus consisted of an oddball paradigm with 2 sound stimuli. Stimuli were presented through headphones and auditory stimulation for P300 was assessed in a recording lasting up to 10 minutes. It was calculated as the average across the pre-dose values at Baseline visit. Baseline was defined as Day 1.
1 secondary outcome
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at Baseline
Time frame: At Baseline (Day 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21514250McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21.
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.
13 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 ATH-1017 in people with Alzheimer Disease and Dementia of Alzheimer Type, run by LeonaBio at 13 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 8 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 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Australia. 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 12 Jun 2023). 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?
Event-related Potential (ERP) P300 Latency at Baseline (time frame: At Baseline (Day 1)). 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 NCT04491006, 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 12 Jun 2023.