Alzheimer DiseasePhase 2INVOKE-2NCT04592874
A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease
A Phase 2 study testing AL002 in people with Alzheimer Disease, run by Alector Inc. at 87 sites in 12 countries.
Trial summary
A phase 2 randomized, double blind, placebo controlled study evaluating the efficacy and safety of AL002 in participants with Early Alzheimer's Disease. 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?
- AL002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 356 participants
- Where
- 87 sitesin 12 countries
- Study dates
- 22 Jan 2021to 12 Sep 2024
- 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 Early AD including evidence of brain amyloidosis by CSF or PET
- MMSE score ≥ 20 points, CDR Global Score of 0.5 - 1.0, and RBANS score on the DMI ≤95.
- Study partner who consents to study participation and who cares for/visits the participant at least 10 hours a week
- Written informed consent must be obtained and documented (from the participant or, where jurisdictions allow it, from their legal decision maker).
Who cannot join
- Dementia due to a condition other than AD including, but not limited to, FTD, Parkinson's disease, dementia with Lewy bodies, Huntington disease, or vascular dementia.
- Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
- Current uncontrolled hypertension, diabetes mellitus or thyroid disease. Clinically significant heart disease, liver disease or kidney disease.
- History or evidence of clinically significant brain disease other than AD.
- Females who are pregnant or breastfeeding, or planning to conceive within the study period.
- Any experimental vaccine or gene therapy.
Show all 10Show fewer
- History of unresolved cancer.
- Current use of anticoagulant medications.
- Residence in a skilled nursing facility, convalescent home, or long term care facility at screening; or requires continuous nursing care.
- Participant is positive for presence of APOE e4/e4 genotype.
Trial locations and contacts
87 sites in 12 countries.
87 sites in 12 countries
United States29 sites
Abington Neurologic Associates
Abington, Pennsylvania, 19090
Emory University
Atlanta, Georgia, 30322
South Florida Neurology Associates
Boca Raton, Florida, 33487
University of Cincinnati MC
Cincinnati, Ohio, 45219
ATP Clinical Research
Costa Mesa, California, 92626
Brain Matters Research - ERG
Delray Beach, Florida, 33445
AMITA Health Clinical Research Institute
Elk Grove Village, Illinois, 60007
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401
Clinical Trial Network
Houston, Texas, 77074-2085
Charter Research
Lady Lake, Florida, 32159
University of Kentucky
Lexington, Kentucky, 40536
ClinCloud, LLC
Maitland, Florida, 32751
K2 Medical Research
Maitland, Florida, 32751
Feinstein Institute For MR
Manhasset, New York, 11030
Advanced Clinical Institute
Neptune City, New Jersey, 07753
Columbia University College of Physicians and Surgeons
New York, New York, 10032-3725
Boston Center for Memory
Newton, Massachusetts, 02459
K2 Winter Garden Ocoee
Ocoee, Florida, 34761
Banner Alzheimer's Institute
Phoenix, Arizona, 85006
Progressive Medical Research
Port Orange, Florida, 32127-5170
Summit Research Network
Portland, Oregon, 97210
University of Rochester Medical Center
Rochester, New York, 14620
Woodlands Research Network, LLC - ERG
Rogers, Arkansas, 72758
SUNY Upstate Medical Center
Syracuse, New York, 13210
Axiom Clinical Research FL
Tampa, Florida, 33609
K2 The Villages
The Villages, Florida, 32159
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Alzheimers Research and Treatment Center
Wellington, Florida, 33449
Conquest Clinical Research (Winter Park)
Winter Park, Florida, 32789
Italy10 sites
IRCCS - Centro S. Giovanni di Dio Fatebenefratelli
Brescia, Lombardy, 25125
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
Brescia, 25123
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, 20122
Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta
Milan, 20133
Ospedale Civile di Baggiovara
Modena, 41126
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
Ospedale degli Infermi
Ponderano, 13875
Fondazione Policlinico Universitario A Gemelli
Rome, Lazio, 00168
Azienda Policlinico Umberto I
Rome, Lazio, 00185
Ospedale S Giovanni Calibita Fatebenefratelli
Rome, Lazio, 00186
Spain9 sites
Hospital de La Santa Creu i Sant Pau
Barcelona, Catalonia, 08041
Fundacion ACE Instituto Catalan de Neurociencias
Barcelona, 08028
Hospital Clinic de Barcelona
Barcelona, 08036
Fundacion CITA Alzheimer Fundazioa
Donostia / San Sebastian, Guipuzcoa, 20009
Centro de Atencion Especializada Oroitu
Getxo, Basque Country, 48993
Hospital Universitario Ramon y Cajal
Madrid, 28034
Hospital Universitario Doctor Peset
Valencia, 46017
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026
Hospital Viamed Montecanal
Zaragoza, 50012
Canada8 sites
True North Clinical Research - Halifax
Halifax, Nova Scotia, B3S 1N2
Okanagan Clinical Trials
Kelowna, British Columbia, V1Y 1Z9
Parkwood Institute
London, Ontario, N6C 0A7
True North Clinical Research - New Minas
New Minas, Nova Scotia, B4N 3R7
Bruyère Research Institute
Ottawa, Ontario, K1N 5C8
Kawartha Regional Memory Clinic
Peterborough, Ontario, K9H 2P4
Toronto Memory Clinic
Toronto, Ontario, M3B 2S7
Baycrest Health Sciences
Toronto, Ontario, Ontario
United Kingdom7 sites
Re:Cognition Health Bristol
Bristol, BS32 4SY
Re: Cognition Health - Guildford
Guildford, Surrey, GU2 7YD
Re:Cognition Health London
London, W1G 9JF
The National Hospital for Neurology and Neurosurgery
London, WC1N 3BG
Greater Manchester Mental Health NHS Foundation Trust
Manchester, M8 5RB
Glasgow Memory Clinic
Motherwell, ML1 4UF
Re:Cognition Health Plymouth
Plymouth, Pl6 8BT
Germany6 sites
Charité - Universitätsmedizin Berlin (CBF)
Berlin, 12203
Charite Campus Buch
Berlin, 13125
University Clinic Heidelberg
Mannheim, 68159
LMU Klinikum der Universität München
München, 81377
Klinikum rechts der Isa der Technischen Universitaet Muenchen
München, 81675
Universitätsklinikum Ulm
Ulm, 89081
France5 sites
Hôpital Roger Salengro
Lille, Nord, 59037
Hopital Lariboisiere
Paris, 75010
Hôpital de la Pitié Salpétrière
Paris, 75013
Centre Hospitalier Universitaire de Toulouse
Toulouse, 31059
Gerontopole
Toulouse, 31059
Australia4 sites
Box Hill Hospital
Box Hill, Victoria, 3128
KaRa Institute of Neurological Disease
Macquarie Park, New South Wales, 2113
SMarT Minds WA
Nedlands, Western Australia, 6009
The Alfred Hospital
Parkville, Victoria, 3050
Poland4 sites
EUROMEDIS Sp. z o.o.
Szczecin, West Pomeranian Voivodeship, 70-111
Centrum Medyczne NeuroProtect
Warsaw, Masovian Voivodeship, 01-684
SOMED CR
Warsaw, 01-737
NZOZ Wroclawskie Centrum Alzheimerowskie
Wroclaw, Lower Silesian Voivodeship, 53-110
Argentina2 sites
Instituto Kremer
Córdoba, X5004AOA
Centro de Psiquiatría Biológica Instituto Senecta
Mendoza, 5500
Netherlands2 sites
Brain Research Center Den Bosch
's-Hertogenbosch, North Brabant, 5223 GV
Brain Research Center Amsterdam
Amsterdam, 1081 GN
About this study
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease
A phase 2 randomized, double blind, placebo controlled study evaluating the efficacy and safety of AL002 in participants with Early Alzheimer's Disease.
Read the detailed description
This is a phase 2 randomized, double blind, placebo controlled study evaluating the efficacy and safety of AL002 administered intravenously in participants with Early Alzheimer's Disease.
- Conditions
- Alzheimer Disease
- Being tested
- AL002, 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.
AL002Drug
Administered via intravenous (IV) infusion
PlaceboDrug
Administered via intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| AL002 Dose 1 | Experimental | AL002 every 4 weeks Receives: Drug: AL002 |
| AL002 Dose 2 | Experimental | AL002 every 4 weeks Receives: Drug: AL002 |
| AL002 Dose 3 | Experimental | AL002 every 4 weeks Receives: Drug: AL002 |
| Placebo | Placebo comparator | Placebo every 4 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Progression as Measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score
Change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) score at Weeks 24, 48, 72 and 96.
The CDR-SB is a tool used to measure disease severity in Alzheimer's disease. This scale assesses three domains of cognition and three domains of function. The domains are rated on a 5 point scale in which the higher the score corresponds to greater cognitive impairment. The scale range is from 0 to 18 where 0 is considered normal and 18 indicates severe dementia.
Measured: Study completion up to 96 weeks
Secondary outcomes (5)
Change in Mini-Mental Status Examination (MMSE) Score
Change from baseline in Mini-Mental Status Examination (MMSE) score at Weeks 24, 48, 72, and 96
The MMSE is a test that assesses orientation, registration, attention and calculation, recent memory, language and constructional praxis. There is a total possible score of 30 with a lower score correlating to a higher cognitive impairment. A score of 24 to 30 is considered normal or no cognitive impairment. A score of 18 to 24 indicates mild impairment. A score of 0 to 17 indicates a severe impairment.
Measured: Study completion up to 96 weeks
Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score
Change from baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score at Weeks 24, 48, 72 and 96
The RBANS test is a collection of 12 subsets representing 5 neurological domains: immediate memory, visuospatial/constructional, language, attention, and delayed memory. The scores are converted to a scale that can range from 40 to 160. The lower the score the greater the cognitive impairment.
Measured: Study completion up to 96 weeks
Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score
Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) score at Weeks 24, 48, 72, and 96
The ADAS-Cog13 is a scale that includes 13 items to assess cognitive function. These domains include memory, language, praxis, and orientation, as well as a number cancellation task and a delayed free recall task. There is a total score range of 0 to 85. A higher score on this scale indicates greater cognitive impairment. There are currently no universally accepted severity bands for ADAS-Cog13 as it is used to track changes in disease and not for severity.
Measured: Study completion up to 96 weeks
Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL-MCI) Score
Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL-MCI) score at Weeks 24, 48, 72, and 96
The ADCS-ADL-MCI is a scale for participants with mild cognitive impairment that observes their performance in completing activities associated with daily living. This scale is a multiple choice questionnaire and has a range of 0 to 53. A lower score on this scale indicates greater cognitive impairment.
Measured: Study completion up to 96 weeks
Change in Alzheimer's Disease Composite Score (ADCOMS) Score
Change from baseline in Alzheimer's Disease Composite Score (ADCOMS) score at Weeks 24, 48, 72, and 96
The ADCOMS scale is a composite score of 12 components that include 4 items from the ADAS-Cog13, 2 items from the MMSE, and all 6 items from the CDR-SB scales. The range of the ADCOMS is between 0 and 1.97. The higher the score the greater the cognitive impairment.
Measured: Study completion up to 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start22 Jan 2021
- Primary completion19 Aug 2024
- Study completion12 Sep 2024
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 (4)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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alector Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Catherine Mummery, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592874
- Sponsor's protocol ID
- AL002-2
- Acronym
- INVOKE-2
- Status last verified
- Aug 2025
- First submitted
- 17 Sep 2020
- Last updated
- 29 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mummery CJ, Mayorga AJ, Simmons A, Chow TW, Burgess B, Nguyen T, Gao J, Budda B, Park LQ, Gupta R, Li C, Shi L, Kenkare-Mitra S, Rosenthal A, Paul R, Ward M, Purcell DD, Salloway S, Grundman M, Romano G, Salvadore G. The TREM2 agonistic antibody AL002 in early Alzheimer's disease: a phase 2 randomized trial. Nat Med. 2026 May;32(5):1708-1716. doi: 10.1038/s41591-026-04273-1. Epub 2026 Mar 5.
PubMed 41787076Shao Q, Chen S, Zheng Y, Xu W, Chen J, Shao W, Wang Q, Li C, Wang X. Crucial role of microglia-mediated myelin sheath damage in vascular dementia: Antecedents and consequences. Neural Regen Res. 2026 Mar 1;21(3):1000-1012. doi: 10.4103/NRR.NRR-D-24-01109. Epub 2025 Mar 25.
PubMed 40145953De Deyn L, Sleegers K. The impact of rare genetic variants on Alzheimer disease. Nat Rev Neurol. 2025 Mar;21(3):127-139. doi: 10.1038/s41582-025-01062-1. Epub 2025 Feb 4.
PubMed 39905212Brodtmann A, Darby D, Oboudiyat C, Mahoney CJ, Le Heron C, Panegyres PK, Brew B. Assessing preparedness for Alzheimer disease-modifying therapies in Australasian health care systems. Med J Aust. 2023 Apr 3;218(6):247-249. doi: 10.5694/mja2.51880. Epub 2023 Mar 19. No abstract available.
PubMed 36934371
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04592874
- Acronym / sponsor ID
- INVOKE-2 / AL002-2
- Conditions
- Alzheimer Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Alector Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 19 Aug 2024 (actual)
- Study completion
- 12 Sep 2024 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Posted 29 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 2 randomized, double blind, placebo controlled study evaluating the efficacy and safety of AL002 in participants with Early Alzheimer's Disease.
Detailed description
This is a phase 2 randomized, double blind, placebo controlled study evaluating the efficacy and safety of AL002 administered intravenously in participants with Early Alzheimer's Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AL002 Dose 1 | Experimental | Drug: AL002AL002 every 4 weeks |
| AL002 Dose 2 | Experimental | Drug: AL002AL002 every 4 weeks |
| AL002 Dose 3 | Experimental | Drug: AL002AL002 every 4 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo every 4 weeks |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Early AD including evidence of brain amyloidosis by CSF or PET
- MMSE score ≥ 20 points, CDR Global Score of 0.5 - 1.0, and RBANS score on the DMI ≤95.
- Study partner who consents to study participation and who cares for/visits the participant at least 10 hours a week
- Written informed consent must be obtained and documented (from the participant or, where jurisdictions allow it, from their legal decision maker).
Key exclusion criteria (10 listed)
- Dementia due to a condition other than AD including, but not limited to, FTD, Parkinson's disease, dementia with Lewy bodies, Huntington disease, or vascular dementia.
- Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
- Current uncontrolled hypertension, diabetes mellitus or thyroid disease. Clinically significant heart disease, liver disease or kidney disease.
- History or evidence of clinically significant brain disease other than AD.
- Females who are pregnant or breastfeeding, or planning to conceive within the study period.
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 |
|---|---|---|
| AL002Administered via intravenous (IV) infusion | Drug | AL002 Dose 1, AL002 Dose 2, AL002 Dose 3 |
| PlaceboAdministered via intravenous (IV) infusion | Drug | Placebo |
Primary outcome
Disease Progression as Measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score
Time frame: Study completion up to 96 weeks
Change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) score at Weeks 24, 48, 72 and 96. The CDR-SB is a tool used to measure disease severity in Alzheimer's disease. This scale assesses three domains of cognition and three domains of function. The domains are rated on a 5 point scale in which the higher the score corresponds to greater cognitive impairment. The scale range is from 0 to 18 where 0 is considered normal and 18 indicates severe dementia.
5 secondary outcomes
Change in Mini-Mental Status Examination (MMSE) Score
Time frame: Study completion up to 96 weeks
Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score
Time frame: Study completion up to 96 weeks
Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score
Time frame: Study completion up to 96 weeks
Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL-MCI) Score
Time frame: Study completion up to 96 weeks
Change in Alzheimer's Disease Composite Score (ADCOMS) Score
Time frame: Study completion up to 96 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41787076Mummery CJ, Mayorga AJ, Simmons A, Chow TW, Burgess B, Nguyen T, Gao J, Budda B, Park LQ, Gupta R, Li C, Shi L, Kenkare-Mitra S, Rosenthal A, Paul R, Ward M, Purcell DD, Salloway S, Grundman M, Romano G, Salvadore G. The TREM2 agonistic antibody AL002 in early Alzheimer's disease: a phase 2 randomized trial. Nat Med. 2026 May;32(5):1708-1716. doi: 10.1038/s41591-026-04273-1. Epub 2026 Mar 5.
- Derived from this study: PubMed 40145953Shao Q, Chen S, Zheng Y, Xu W, Chen J, Shao W, Wang Q, Li C, Wang X. Crucial role of microglia-mediated myelin sheath damage in vascular dementia: Antecedents and consequences. Neural Regen Res. 2026 Mar 1;21(3):1000-1012. doi: 10.4103/NRR.NRR-D-24-01109. Epub 2025 Mar 25.
- Derived from this study: PubMed 39905212De Deyn L, Sleegers K. The impact of rare genetic variants on Alzheimer disease. Nat Rev Neurol. 2025 Mar;21(3):127-139. doi: 10.1038/s41582-025-01062-1. Epub 2025 Feb 4.
- Derived from this study: PubMed 36934371Brodtmann A, Darby D, Oboudiyat C, Mahoney CJ, Le Heron C, Panegyres PK, Brew B. Assessing preparedness for Alzheimer disease-modifying therapies in Australasian health care systems. Med J Aust. 2023 Apr 3;218(6):247-249. doi: 10.5694/mja2.51880. Epub 2023 Mar 19. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Catherine Mummery principal investigator
87 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AL002 in people with Alzheimer Disease, run by Alector Inc. at 87 sites in 12 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 4 inclusion and 10 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 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 87 sites in United States, Italy, Spain, Canada, United Kingdom and 7 more countries. 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 29 Oct 2025). 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?
Disease Progression as Measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score (time frame: Study completion up to 96 weeks). 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 NCT04592874, which also lists 4 linked publications.
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 29 Oct 2025.