Alzheimer's Disease DementiaPhase 3ATHENE IINCT07191028
Alzheimer's Disease THErapy With NEuroaid II
A Phase 3 study testing MLC 901 in people with Alzheimer's Disease Dementia, run by Moleac Pte Ltd. at 1 site in Singapore.
Trial summary
ATHENE II is a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial designed to evaluate the efficacy and safety of MLC901 in subjects with mild to moderate Alzheimer's disease, as well as its effects on plasma biomarkers compared to placebo. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease Dementia
- What is being tested?
- MLC 901
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteSingapore
- Study dates
- Aug 2026to May 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Male or female subjects aged ≥ 50 years at the time of providing informed consent.
- Diagnosis of AD based on the National Institute on Ageing and the Alzheimer's Association (NIA-AA) criteria, supported by the presence of a Core 1 AD biomarker, specifically elevated plasma ptau217 ≥0.471 pg/mL.
- MMSE score between 10 and 26, inclusive, at baseline, corresponding to mild to moderate AD.
- Subjects may be either treatment-naïve or currently receiving stable symptomatic treatment for AD for at least the 2 months prior to screening, including AChEIs, memantine, or a combination of both.
- Subjects must have a designated study partner who provides ongoing support during the study and interacts with the subject for a minimum of 8 hours per week, and will accompany the subject to study visits or be available by telephone at designated times.
- A second study partner may serve as backup. If the original study partner withdraws from participation, a replacement study partner may be permitted at the investigator's discretion. The replacement study partner must provide informed consent prior to their first study visit with the subject.
- Both the subject (or their legally authorized representative) and the study partner(s) must be capable of providing informed consent.
- Subjects must have adequate literacy, vision, and hearing, in the opinion of the investigator at the time of screening, to allow for valid administration of the clinical outcome assessments.
Who cannot join
- Presence of any neurological disorder contributing to cognitive impairment other than AD, including but not limited to: Parkinson's disease, Dementia with Lewy bodies, and epilepsy or recurrent seizures.
- Evidence of other clinically significant cerebrovascular disease or intracranial abnormalities based on the latest brain CT or MRI, including but not limited to: multiple lacunar infarcts, large territorial infarcts, severe small vessel or white matter disease, normal pressure hydrocephalus, space occupying lesions.
- The most recent available scan (obtained at diagnosis or subsequently) is usually sufficient for screening eligibility to exclude these other conditions. Repeat imaging may need in some cases to be considered if there is clinically significant deterioration or new neurological signs suggestive of a cerebrovascular event.
- Presence of any serious or unstable medical illnesses, including but not limited to: cardiovascular, respiratory, gastroenterological, endocrinologic, immunologic, hematologic, hepatic, or renal and other conditions, that, in the investigator's judgment, may interfere with study participation or compromise subject safety.
- Patients with a CDR Global Score of 0, 0.5 or 3 at the Screening Phase, corresponding to no, very mild or severe dementia, respectively, will be excluded from the study.
- Severe visual or hearing impairment that would prevent the subject from accurately completing clinical outcome assessments.
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- Serum creatinine > 130 µmol/L at baseline, which may affect plasma biomarker analysis.
- Female subjects who are pregnant at screening.
- Participation in another clinical trial or receipt of any investigational product within 60 days or 5 half-lives (whichever is longer) prior to screening.
- Current use at baseline of any AD disease modifying therapies including anti-amyloid therapy or neuroprotective/nootropic agents, including Ginkgo biloba, Neurotain, Citicoline, Cerebrolysin, or Piracetam.
- Known hypersensitivity or allergic reaction to MLC901 or any of its components. Any known food allergy or hypersensitivity to Astragalus membranaceus, Ligusticum chuanxiong, Polygala tenuifolia, Angelica sinensis or members of the Fabaceae/Leguminosae family (e.g., legume, pea, bean), Polygalaceae family (e.g., milkwort, snakeroot), Apiaceae/Umbelliferae family (e.g., anise, caraway, carrot, celery, dill, parsley, parsnip) or Quillaja bark (soapbark).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site
National University Hospital Singapore
Singapore
Christopher Li Hsian Chen, +65 66015668, Christopher_CHEN@nuhs.edu.sg
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parellel-group Study to Assess the Efficacy and Safety of MLC901 (NeuroAiD™II) in Subjects With Mild to Moderate Alzheimer's Disease (AD).
ATHENE II is a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial designed to evaluate the efficacy and safety of MLC901 in subjects with mild to moderate Alzheimer's disease, as well as its effects on plasma biomarkers compared to placebo.
Read the detailed description
Alzheimer's disease (AD) is a progressive neurodegenerative disorder with limited treatments that slow progression. Current symptomatic therapies provide modest benefit, while anti-amyloid agents target a single pathway and have uncertain long-term outcomes. Multitarget approaches may provide broader and more durable benefit. MLC901 (NeuroAiD™II), a Traditional Chinese Medicine derived formulation, has shown neuroprotective and neuroproliferative properties in preclinical studies through multimodal mechanisms, including modulation of amyloid beta and tau phosphorylation, reduction of oxidative stress and inflammation, and promotion of neurogenesis and synaptogenesis. Clinical studies, including the ATHENE trial, suggest MLC901 may slow cognitive decline and is well tolerated. ATHENE II is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study enrolling approximately 350 patients with mild to moderate AD across Southeast Asia. Participants will receive MLC901 or placebo for 12 months. The primary objective is to determine whether MLC901 is superior to placebo in slowing cognitive decline as measured by ADAS-Cog11. Secondary and exploratory objectives include global cognition, function, behavior, safety, and plasma biomarkers of AD (p-tau217, NfL and GFAP).
- Conditions
- Alzheimer's Disease Dementia
- Being tested
- MLC 901, Placebo
- Keywords
- MLC901, NeuroAiD™II, Alzheimer's disease, multicenter, randomised, double blind, placebo controlled
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLC 901Drug
Oral capsule, 2 capsules 3 times a day for 12 months
PlaceboDrug
Oral capsule, 2 capsules 3 times a day for 12 months
| Study group | Role | What they receive |
|---|---|---|
| MLC901 | Experimental | Active arm Receives: Drug: MLC 901 |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's Disease Assessment Scale-Cognitive Subscale11 (ADAS-Cog11)
The ADAS-Cog is a rater-administered instrument designed to assess the severity of cognitive impairment and associated non-cognitive behaviors characteristic of individuals with AD. It is the most widely used cognitive scale in clinical trials evaluating treatments for mild to moderate AD.
For this study, the version of ADAS-Cog11 will be used as the primary efficacy assessment. The ADAS Cog11 consists of 11 items assessing key areas of cognitive function that are commonly impaired in AD, including: orientation, word recall, word recognition, remembering word recognition test instructions, commands, comprehension of spoken language, naming, word-finding difficulty, spoken language ability, construction praxis, and ideational praxis.
The ADAS-Cog11 total score ranges from 0 to 70, with higher scores indicating greater cognitive impairment.
Measured: Baseline, Month 6 and Month 12
Secondary outcomes (4)
Clinical Dementia Rating (CDR): Global Score and Sum of Boxes (CDR-SB)
The CDR evaluates both cognitive and functional domains through structured interviews conducted with both the participant and a knowledgeable informant (such as a caregiver or study partner). The assessment is administered by a trained assessor according to a standardized protocol. The CDR includes the following 6 domains: 3 cognitive domains (memory, orientation, and judgment/problem solving) and 3 functional domains (community activities, home and leisure, and personal care). Each domain is rated on a scale from 0 (no impairment) to 3 (severe impairment). The CDR yield 2 scores, including CDR Global Score and CDR-SB. The CDR global score: a categorical rating from 0 to 3, derived via a standardized algorithm. This score is used to stage the severity of dementia as follows: 0= No dementia; 0.5= Very mild dementia; 1= Mild dementia; 2= Moderate dementia; 3= Severe dementia. CDR-SB: a continuous score ranging from 0 to 18, calculated by summing the individual domain scores.
Measured: Baseline, Month 6 and Month 12
Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)
The ADCS-ADL, developed by Galasko et al, is the most widely used instrument for assessing functional outcomes in patients with AD. This 23-item scale evaluates both basic activities of daily living-such as eating and toileting-and more complex instrumental activities of daily living. The ADCS-ADL is administered as a structured interview with the participant's study partner or caregiver. For each item, the study partner is first asked whether the participant attempted the activity within the past four weeks. If so, the study partner is then asked to describe the participant's performance, which is scored accordingly.
The total ADCS-ADL score ranges from 0 to 78, with lower scores indicating greater functional impairment.
Measured: Baseline, Month 6 and Month 12
Neuropsychiatric Inventory (NPI)
The NPI is a validated instrument developed to assess a broad spectrum of behavioral and psychological symptoms commonly observed in individuals with dementia. The purpose of the NPI is to characterize the presence and severity of these symptoms. The questionnaire assesses 12 neuropsychiatric symptom domains: delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, aberrant motor behavior, nighttime disturbances, and appetite/eating abnormalities.
For each symptom domain, both frequency and severity are assessed. Severity is rated on a 3-point scale (mild, moderate, or marked), while caregiver distress related to each symptom is also rated on a 6-point scale (ranging from no distress to very severe distress). The NPI is administered via a structured interview with the subject's study partner or caregiver, who provides observations based on the subject's behavior.
Measured: Baseline, Month 6 and Month 12
Adverse events
Listing and calculating the number and percentage of subjects experiencing non-serious and serious adverse events for each arm.
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study startAug 2026 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's Disease DementiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, parellel-group study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moleac Pte Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National University Hospital, Singapore
- Responsible party
- Sponsor
- Investigators
- Christopher Li Hsian Chen, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191028
- Sponsor's protocol ID
- EFSA2025_01
- Acronym
- ATHENE II
- Status last verified
- Jun 2026
- First submitted
- 2 Sep 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual participant data (IPD) for this study. Only de-identified, aggregate study findings will be disseminated through scientific meetings and peer-reviewed publications.
Publications
Dib M, Ampil E, Kee HF, et al. A review of NeuroAiD™ II (MLC901) development in Alzheimer's disease treatment: promises of a multimodal pathway. J Neurol Res Rev Rep. 2022 Jun 30;1-13.
Lee WT, Hsian CCL, Lim YA. The effects of MLC901 on tau phosphorylation. Neuroreport. 2017 Nov 8;28(16):1043-1048. doi: 10.1097/WNR.0000000000000884.
PubMed 28902708Lim YA, Murray LA, Lai MK, Chen C. NeuroAiD(R) (MLC601) and amyloid precursor protein processing. Cerebrovasc Dis. 2013;35 Suppl 1:30-7. doi: 10.1159/000346236. Epub 2013 Mar 14.
PubMed 23548917Heurteaux C, Widmann C, Moha ou Maati H, Quintard H, Gandin C, Borsotto M, Veyssiere J, Onteniente B, Lazdunski M. NeuroAiD: properties for neuroprotection and neurorepair. Cerebrovasc Dis. 2013;35 Suppl 1:1-7. doi: 10.1159/000346228. Epub 2013 Mar 14.
PubMed 23548913Heurteaux C, Gandin C, Borsotto M, Widmann C, Brau F, Lhuillier M, Onteniente B, Lazdunski M. Neuroprotective and neuroproliferative activities of NeuroAid (MLC601, MLC901), a Chinese medicine, in vitro and in vivo. Neuropharmacology. 2010 Jun;58(7):987-1001. doi: 10.1016/j.neuropharm.2010.01.001. Epub 2010 Jan 11.
PubMed 20064536
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Parellel-group Study to Assess the Efficacy and Safety of MLC901 (NeuroAiD™II) in Subjects With Mild to Moderate Alzheimer's Disease (AD).
- ClinicalTrials.gov ID
- NCT07191028
- Acronym / sponsor ID
- ATHENE II / EFSA2025_01
- Conditions
- Alzheimer's Disease Dementia
- Keywords
- MLC901, NeuroAiD™II, Alzheimer's disease, multicenter, randomised, double blind, placebo controlled
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Moleac Pte Ltd.Industry (pharma, biotech, devices)
- Collaborators
- National University Hospital, Singapore
- Study start
- Aug 2026 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 24 Sep 2025 (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.
ATHENE II is a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial designed to evaluate the efficacy and safety of MLC901 in subjects with mild to moderate Alzheimer's disease, as well as its effects on plasma biomarkers compared to placebo.
Detailed description
Alzheimer's disease (AD) is a progressive neurodegenerative disorder with limited treatments that slow progression. Current symptomatic therapies provide modest benefit, while anti-amyloid agents target a single pathway and have uncertain long-term outcomes. Multitarget approaches may provide broader and more durable benefit. MLC901 (NeuroAiD™II), a Traditional Chinese Medicine derived formulation, has shown neuroprotective and neuroproliferative properties in preclinical studies through multimodal mechanisms, including modulation of amyloid beta and tau phosphorylation, reduction of oxidative stress and inflammation, and promotion of neurogenesis and synaptogenesis. Clinical studies, including the ATHENE trial, suggest MLC901 may slow cognitive decline and is well tolerated. ATHENE II is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study enrolling approximately 350 patients with mild to moderate AD across Southeast Asia. Participants will receive MLC901 or placebo for 12 months. The primary objective is to determine whether MLC901 is superior to placebo in slowing cognitive decline as measured by ADAS-Cog11. Secondary and exploratory objectives include global cognition, function, behavior, safety, and plasma biomarkers of AD (p-tau217, NfL and GFAP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, parellel-group study
| Arm | Type | Receives |
|---|---|---|
| MLC901 | Experimental | Drug: MLC 901Active arm |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects aged ≥ 50 years at the time of providing informed consent.
- Diagnosis of AD based on the National Institute on Ageing and the Alzheimer's Association (NIA-AA) criteria, supported by the presence of a Core 1 AD biomarker, specifically elevated plasma ptau217 ≥0.471 pg/mL.
- MMSE score between 10 and 26, inclusive, at baseline, corresponding to mild to moderate AD.
- Subjects may be either treatment-naïve or currently receiving stable symptomatic treatment for AD for at least the 2 months prior to screening, including AChEIs, memantine, or a combination of both.
- Subjects must have a designated study partner who provides ongoing support during the study and interacts with the subject for a minimum of 8 hours per week, and will accompany the subject to study visits or be available by telephone at designated times.
Key exclusion criteria (11 listed)
- Presence of any neurological disorder contributing to cognitive impairment other than AD, including but not limited to: Parkinson's disease, Dementia with Lewy bodies, and epilepsy or recurrent seizures.
- Evidence of other clinically significant cerebrovascular disease or intracranial abnormalities based on the latest brain CT or MRI, including but not limited to: multiple lacunar infarcts, large territorial infarcts, severe small vessel or white matter disease, normal pressure hydrocephalus, space occupying lesions.
- The most recent available scan (obtained at diagnosis or subsequently) is usually sufficient for screening eligibility to exclude these other conditions. Repeat imaging may need in some cases to be considered if there is clinically significant deterioration or new neurological signs suggestive of a cerebrovascular event.
- Presence of any serious or unstable medical illnesses, including but not limited to: cardiovascular, respiratory, gastroenterological, endocrinologic, immunologic, hematologic, hepatic, or renal and other conditions, that, in the investigator's judgment, may interfere with study participation or compromise subject safety.
- Patients with a CDR Global Score of 0, 0.5 or 3 at the Screening Phase, corresponding to no, very mild or severe dementia, respectively, will be excluded from the study.
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 |
|---|---|---|
| MLC 901Oral capsule, 2 capsules 3 times a day for 12 months | Drug | MLC901 |
| PlaceboOral capsule, 2 capsules 3 times a day for 12 months | Drug | Placebo |
Primary outcome
Alzheimer's Disease Assessment Scale-Cognitive Subscale11 (ADAS-Cog11)
Time frame: Baseline, Month 6 and Month 12
The ADAS-Cog is a rater-administered instrument designed to assess the severity of cognitive impairment and associated non-cognitive behaviors characteristic of individuals with AD. It is the most widely used cognitive scale in clinical trials evaluating treatments for mild to moderate AD. For this study, the version of ADAS-Cog11 will be used as the primary efficacy assessment. The ADAS Cog11 consists of 11 items assessing key areas of cognitive function that are commonly impaired in AD, including: orientation, word recall, word recognition, remembering word recognition test instructions, commands, comprehension of spoken language, naming, word-finding difficulty, spoken language ability, construction praxis, and ideational praxis. The ADAS-Cog11 total score ranges from 0 to 70, with higher scores indicating greater cognitive impairment.
4 secondary outcomes
Clinical Dementia Rating (CDR): Global Score and Sum of Boxes (CDR-SB)
Time frame: Baseline, Month 6 and Month 12
Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)
Time frame: Baseline, Month 6 and Month 12
Neuropsychiatric Inventory (NPI)
Time frame: Baseline, Month 6 and Month 12
Adverse events
Time frame: Up to 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- BackgroundDib M, Ampil E, Kee HF, et al. A review of NeuroAiD™ II (MLC901) development in Alzheimer's disease treatment: promises of a multimodal pathway. J Neurol Res Rev Rep. 2022 Jun 30;1-13.
- Background: PubMed 28902708Lee WT, Hsian CCL, Lim YA. The effects of MLC901 on tau phosphorylation. Neuroreport. 2017 Nov 8;28(16):1043-1048. doi: 10.1097/WNR.0000000000000884.
- Background: PubMed 23548917Lim YA, Murray LA, Lai MK, Chen C. NeuroAiD(R) (MLC601) and amyloid precursor protein processing. Cerebrovasc Dis. 2013;35 Suppl 1:30-7. doi: 10.1159/000346236. Epub 2013 Mar 14.
- Background: PubMed 23548913Heurteaux C, Widmann C, Moha ou Maati H, Quintard H, Gandin C, Borsotto M, Veyssiere J, Onteniente B, Lazdunski M. NeuroAiD: properties for neuroprotection and neurorepair. Cerebrovasc Dis. 2013;35 Suppl 1:1-7. doi: 10.1159/000346228. Epub 2013 Mar 14.
- Background: PubMed 20064536Heurteaux C, Gandin C, Borsotto M, Widmann C, Brau F, Lhuillier M, Onteniente B, Lazdunski M. Neuroprotective and neuroproliferative activities of NeuroAid (MLC601, MLC901), a Chinese medicine, in vitro and in vivo. Neuropharmacology. 2010 Jun;58(7):987-1001. doi: 10.1016/j.neuropharm.2010.01.001. Epub 2010 Jan 11.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data (IPD) for this study. Only de-identified, aggregate study findings will be disseminated through scientific meetings and peer-reviewed publications.
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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.
Christopher Li Hsian Chen principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MLC 901 in people with Alzheimer's Disease Dementia, run by Moleac Pte Ltd. at 1 site in Singapore.
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 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: opening soon, as of the sponsor's last update on 12 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 1 site in Singapore. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mei Fen Sung (+65 62113710 ext. 183, mea.sung@moleac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alzheimer's Disease Assessment Scale-Cognitive Subscale11 (ADAS-Cog11) (time frame: Baseline, Month 6 and Month 12). 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 NCT07191028, which also lists 5 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 12 Jun 2026.