Early Alzheimer's DiseasePhase 3APOLLOE4-LTENCT06304883
Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects
A Phase 3 study testing Experimental: ALZ-801 in people with Early Alzheimer's Disease, run by Alzheon Inc. at 41 sites in 3 countries.
Trial summary
This study is being conducted to evaluate the long-term safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is an open-label trial of treatment with ALZ-801. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Early Alzheimer's Disease
- What is being tested?
- Experimental: ALZ-801
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 41 sitesin 3 countries
- Study dates
- 2 Apr 2024to 11 Mar 2026
- Phase
- Phase 3
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has completed the Week 78 of the Phase 3 core study (ALZ-801-AD301) while on study drug.
- Subject has a reliable study partner who has sufficient contact with the subject to be able to provide accurate information about the subject's cognitive and functional abilities.
Who cannot join
- Significant worsening of medical conditions that may preclude completion of this study.
- Evidence of symptomatic or new moderate-severe radiologic ARIA at baseline.
- Has received (or plans to receive) amyloid antibodies since completing Phase 3 core study (ALZ-801-AD301).
- Subject taking any prohibited medications per protocol.
Trial locations and contacts
41 sites in 3 countries.
41 sites in 3 countries
United States29 sites
Abington Neurological Associates
Abington, Pennsylvania, 19001
Neurological Associates of Albany
Albany, New York, 12208
JEM Research Institute, Headlands Site
Atlantis, Florida, 33462
Northwest Clinical Research Center
Bellevue, Washington, 98007
Columbus Memory Center
Columbus, Georgia, 31909
ATP Clinical Research
Costa Mesa, California, 92626
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, 02914
Re:Cognition Health
Fairfax, Virginia, 22031
Fort Wayne Neurological Center
Fort Wayne, Indiana, 46804
Triad Clinical Trials
Greensboro, North Carolina, 27410
UT Health Science Center at Houston
Houston, Texas, 77054
Torrance Clinical Research Institute
Lomita, California, 90717
K2 Medical Research, LLC
Maitland, Florida, 32751
AMC Research
Matthews, North Carolina, 28105
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Aqualane Clinical Research
Naples, Florida, 34105
NYU Alzheimer's Disease Research Center
New York, New York, 10016
Charter Research
Orlando, Florida, 32803
Xenoscience, Inc.
Phoenix, Arizona, 85004
Headlands Research Eastern MA
Plymouth, Massachusetts, 02360
Progressive Medical Research
Port Orange, Florida, 32127
Center for Cognitive Health
Portland, Oregon, 97225
University of Rochester Medical Center
Rochester, New York, 14620
Sutter Health
Sacramento, California, 95816
ALZ Research and Treatment Center (A.R.T.C.)
Stuart, Florida, 34997
Banner Sun Health Research Institute
Sun City, Arizona, 85351
Advanced Memory Research Center
Toms River, New Jersey, 08755
ALZ Research and Treatment Center (A.R.T.C.)
Wellington, Florida, 33414
Premiere Research Institute
West Palm Beach, Florida, 33407
United Kingdom7 sites
Re-Cognition Health Ltd Birmingham
Birmingham, West Midlands, B16 8LT
Re-Cognition Health Ltd Bristol
Bristol, BS32 4SY
Re-Cognition Health Ltd Guildford
Guildford, Surrey, GU2 7YD
Re-Cognition Health Ltd London
London, Greater London, W1G 9JF
NeuroClin Glasgow Ltd
Motherwell, North Lanarkshire, ML1 4UF
Re-Cognition Health Ltd Plymouth
Plymouth, Devon, PL6 8BT
Re-Cognition Health Ltd Winchester
Winchester, SO21 1HU
Canada5 sites
Centricity Research
Halifax, Nova Scotia, B3S 1N2
OCT Research ULC (dba Okanagan Clinical Trials)
Kelowna, British Columbia, V1Y 1Z9
Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic
Ottawa, Ontario, K1Z 1G3
Kawartha Centre - Redefining Healthy Aging
Peterborough, Ontario, K9H 2P4
Toronto Memory Program
Toronto, Ontario, M3B 2S7
About this study
Official title: Long-term Extension of a Phase 3, Multicenter, Randomized, Double-Blind, Placebo- Controlled Study of the Efficacy, Safety, and Biomarker Effects of ALZ-801 in Subjects With Early Alzheimer's Disease and APOE4/4 Genotype
This study is being conducted to evaluate the long-term safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is an open-label trial of treatment with ALZ-801.
Read the detailed description
This is a long-term extension study of the Phase 3, multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and imaging biomarker effects of ALZ-801 in subjects with Early Alzheimer's Disease and APOE4/4 genotype. Subjects who at initial screening for the Phase 3 study were 50-80 years old, had a clinical diagnosis of AD, carried the APOE4/4 genotype, and were at the early stage of disease (Early AD], who complete at least 78 weeks of the Phase 3 study while on study medication, were eligible for enrollment. Subjects will be treated for 104 weeks with ALZ-801, followed by a 4-week safety follow-up visit after the last dose of ALZ-801. Clinical trial sites, subjects and their study partner will remain blinded to the treatment (ALZ-801 or placebo) that they received in the core Phase 3 study. The primary efficacy outcome assessment is a measure of cognition (ADAS-Cog 13). Additional measures of global and functional impairments will also be assessed. Imaging and biomarkers of AD and neurodegeneration will be measured.
- Conditions
- Early Alzheimer's Disease
- Being tested
- Experimental: ALZ-801
- Keywords
- Dementia, Central Nervous System Diseases, Nervous System Diseases, Tauopathies, Neurodegenerative Diseases, Neurocognitive Disorders, Mental Disorders, Alzheimer Disease
- Medical subject headings
- Alzheimer Disease, Dementia, Central Nervous System Diseases, Nervous System Diseases, Tauopathies, Neurodegenerative Diseases, Neurocognitive Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: ALZ-801Drug
ALZ-801 265 mg BID tablet orally.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: ALZ-801 | Experimental | ALZ-801 265 mg BID tablet orally. Subjects will take one 265 mg tablet of ALZ-801 in the evening during the first 4 weeks of the study; thereafter, they will take one 265 mg tablet BID. Receives: Drug: Experimental: ALZ-801 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary cognitive efficacy endpoint 1
Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-Cog 13), from baseline of Phase 3 core study (ALZ-801-AD301) to Week 52 and Week 104 of this long-term extension study (ALZ-801-AD351).
Measured: Week 104
Primary cognitive efficacy endpoint 2
Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-Cog 13), from baseline of this study to Week 52 and Week 104.
Measured: Week 104
Incidence, Nature, and Severity of Treatment Emergent Adverse events (TEAEs)
Safety and tolerability as measured by incidence, nature and severity of treatment emergent adverse events (TEAE), serious TEAE, and TEAE leading to withdrawal.
Measured: Week 104
Primary imaging biomarker endpoint 1
Change from baseline in total hippocampal volume (mm3) as measured by Magnetic Resonance Imaging (MRI), from baseline of the Phase 3 core study (ALZ-801-AD301) to Week 52 and Week 104 of this long-term extension study (ALZ-801-AD351).
Measured: Week 104
Primary imaging biomarker endpoint 2
Change from baseline in total hippocampal volume (mm3) as measured by Magnetic Resonance Imaging (MRI), from baseline of this study to Week 52 and Week 104.
Measured: Week 104
Secondary outcomes (8)
Secondary functional efficacy endpoint
Change from baseline of the Phase 3 core study, and from baseline and from Week 52 of this study, in Disability Assessment for Dementia scores.
Measured: Week 104
Secondary functional efficacy endpoint
Change from baseline of the Phase 3 core study, and from baseline and from Week 52 of this study, in Amsterdam - Instrumental Activities of Daily Living scores.
Measured: Week 104
Secondary global assessment efficacy endpoint
Change from baseline of the Phase 3 core study, and from baseline and from Week 52 of this study, in Clinical Dementia Rating - Sum of Boxes (CDR-SB) scores.
Measured: Week 104
Secondary cognitive efficacy endpoint 1
Change from baseline of the Phase 3 core study, and from baseline and from Week 52 of this study, in Alzheimer's Disease Assessment Scale - Cognitive Subscale 11.
Measured: Week 104
Secondary cognitive efficacy endpoint 2
Change from baseline of the Phase 3 core study, and from baseline and from Week 52 of this study, in Neuropsychiatric Inventory.
Measured: Week 104
Secondary cognitive efficacy endpoint 3
Change from baseline of the Phase 3 core study, and from baseline and from Week 52 of this study, in Mini-Mental State Examination.
Measured: Week 104
Secondary imaging biomarker endpoint
Change from baseline of the Phase 3 core study (ALZ-801-AD301) and from baseline of this long-term extension study (ALZ-801-AD351) in cortical thickness, whole brain volume and ventricular volume (mm3) as measured by Magnetic Resonance Imaging (MRI) to Weeks 26, 52, 78 and 104.
Measured: Week 104
Secondary fluid biomarker endpoint
Change from baseline of the Phase 3 core study, and from baseline and from Week 52 of this study in plasma p-tau181, Aβ 42, Aβ 40, GFAP, and NfL levels.
Measured: Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start2 Apr 2024
- Primary completion11 Mar 2026
- Study completion11 Mar 2026
Why it stopped: Sponsor business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Alzheimer's 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a multi-center, open-label, single group, long-term extension study.
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alzheon Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan Abushakra, MD, Principal investigator, Alzheon Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304883
- Sponsor's protocol ID
- ALZ-801-AD351
- Acronym
- APOLLOE4-LTE
- Status last verified
- Jun 2026
- First submitted
- 5 Mar 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Extension of a Phase 3, Multicenter, Randomized, Double-Blind, Placebo- Controlled Study of the Efficacy, Safety, and Biomarker Effects of ALZ-801 in Subjects With Early Alzheimer's Disease and APOE4/4 Genotype
- ClinicalTrials.gov ID
- NCT06304883
- Acronym / sponsor ID
- APOLLOE4-LTE / ALZ-801-AD351
- Conditions
- Early Alzheimer's Disease
- Keywords
- Dementia, Central Nervous System Diseases, Nervous System Diseases, Tauopathies, Neurodegenerative Diseases, Neurocognitive Disorders, Mental Disorders, Alzheimer Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor business decision
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Alzheon Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 11 Mar 2026 (actual)
- Study completion
- 11 Mar 2026 (actual)
- First posted
- 12 Mar 2024 (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.
This study is being conducted to evaluate the long-term safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is an open-label trial of treatment with ALZ-801.
Detailed description
This is a long-term extension study of the Phase 3, multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and imaging biomarker effects of ALZ-801 in subjects with Early Alzheimer's Disease and APOE4/4 genotype. Subjects who at initial screening for the Phase 3 study were 50-80 years old, had a clinical diagnosis of AD, carried the APOE4/4 genotype, and were at the early stage of disease (Early AD], who complete at least 78 weeks of the Phase 3 study while on study medication, were eligible for enrollment. Subjects will be treated for 104 weeks with ALZ-801, followed by a 4-week safety follow-up visit after the last dose of ALZ-801. Clinical trial sites, subjects and their study partner will remain blinded to the treatment (ALZ-801 or placebo) that they received in the core Phase 3 study. The primary efficacy outcome assessment is a measure of cognition (ADAS-Cog 13). Additional measures of global and functional impairments will also be assessed. Imaging and biomarkers of AD and neurodegeneration will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a multi-center, open-label, single group, long-term extension study.
| Arm | Type | Receives |
|---|---|---|
| Experimental: ALZ-801 | Experimental | Drug: Experimental: ALZ-801ALZ-801 265 mg BID tablet orally. Subjects will take one 265 mg tablet of ALZ-801 in the evening during the first 4 weeks of the study; thereafter, they will take one 265 mg tablet BID. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has completed the Week 78 of the Phase 3 core study (ALZ-801-AD301) while on study drug.
- Subject has a reliable study partner who has sufficient contact with the subject to be able to provide accurate information about the subject's cognitive and functional abilities.
Key exclusion criteria (4 listed)
- Significant worsening of medical conditions that may preclude completion of this study.
- Evidence of symptomatic or new moderate-severe radiologic ARIA at baseline.
- Has received (or plans to receive) amyloid antibodies since completing Phase 3 core study (ALZ-801-AD301).
- Subject taking any prohibited medications per protocol.
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 |
|---|---|---|
| Experimental: ALZ-801ALZ-801 265 mg BID tablet orally. | Drug | Experimental: ALZ-801 |
Primary outcome
Primary cognitive efficacy endpoint 1
Time frame: Week 104
Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-Cog 13), from baseline of Phase 3 core study (ALZ-801-AD301) to Week 52 and Week 104 of this long-term extension study (ALZ-801-AD351).
Primary cognitive efficacy endpoint 2
Time frame: Week 104
Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-Cog 13), from baseline of this study to Week 52 and Week 104.
Incidence, Nature, and Severity of Treatment Emergent Adverse events (TEAEs)
Time frame: Week 104
Safety and tolerability as measured by incidence, nature and severity of treatment emergent adverse events (TEAE), serious TEAE, and TEAE leading to withdrawal.
Primary imaging biomarker endpoint 1
Time frame: Week 104
Change from baseline in total hippocampal volume (mm3) as measured by Magnetic Resonance Imaging (MRI), from baseline of the Phase 3 core study (ALZ-801-AD301) to Week 52 and Week 104 of this long-term extension study (ALZ-801-AD351).
Primary imaging biomarker endpoint 2
Time frame: Week 104
Change from baseline in total hippocampal volume (mm3) as measured by Magnetic Resonance Imaging (MRI), from baseline of this study to Week 52 and Week 104.
8 secondary outcomes
Secondary functional efficacy endpoint
Time frame: Week 104
Secondary functional efficacy endpoint
Time frame: Week 104
Secondary global assessment efficacy endpoint
Time frame: Week 104
Secondary cognitive efficacy endpoint 1
Time frame: Week 104
Secondary cognitive efficacy endpoint 2
Time frame: Week 104
Secondary cognitive efficacy endpoint 3
Time frame: Week 104
Secondary imaging biomarker endpoint
Time frame: Week 104
Secondary fluid biomarker endpoint
Time frame: Week 104
Results and safety
The study was stopped early (reason given: Sponsor business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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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.
Susan Abushakra, MD principal investigator
Alzheon Inc.
41 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental: ALZ-801 in people with Early Alzheimer's Disease, run by Alzheon Inc. at 41 sites in 3 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 2 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 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, United Kingdom, 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?
The study was stopped early (reason given: Sponsor business decision). Results are not available in the source record.
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?
Primary cognitive efficacy endpoint 1 (time frame: Week 104). The study lists 5 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 25 Jun 2026.