Alzheimer DiseasePhase 2NCT05413655
A Study of Oral EX039 in Subjects with Mild Alzheimer's Disease
A Phase 2 study testing EX039 in people with Alzheimer Disease, run by Excelsior at 1 site in Taiwan.
Trial summary
This is a phase 2, randomized, double-blind, placebo-controlled study of oral EX039 as add-on to Acetylcholine Esterase Inhibitors in subjects with mild Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- EX039
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Aug 2022to Feb 2027
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 50-80 years.
- Clinical diagnosis of probable mild Alzheimer disease dementia based on National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA criteria, 2011)
- Last time (which must be within 3 months ) of Mini Mental State Exam (MMSE) between 10-26.
- Last time (which must be within 3 months) of Clinical Dementia Rating (CDR) score of 1.
- Physically healthy and all laboratory assessments (including hematology, chemistry, urinalysis and electrocardiograph) are within normal range or meet the following criteria:
- AST, ALT level ≦ upper limit of normal
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- Creatine Kinase (CK) concentration more than 3 times upper limit of normal
- Serum creatinine level ≦ upper limit of normal
- HbA1c more than 8.0
- Complaints of subjective memory impairment and cognitive disturbances by patients themselves or caregivers, including memory loss and at least one of the following cognitive disturbances: language, perceptual skills, attention, constructive abilities, orientation, problem solving, functional abilities.
- Cognitive deficits caused impairment in social or occupational function.
- Disease progression with gradual and continued decline from a previous level of functioning.
- Female subjects must be of non-childbearing potential (greater than 1 year without menstrual period in the absence of hormone replacement therapy) or surgically sterile. If pre-menopausal or menopausal for 1 year or less, must have a negative pregnancy test and must not be lactating at screening visit. Female subjects of childbearing potential and who are sexually active are required to practice adequate methods of birth control. Male subjects who are sexually active will also be required to use an adequate form of birth control.
- Has sufficient education equivalent to elementary education to communicate effectively and were capable of completing the assessments of the study.
Who cannot join
- Having other causes of dementia.
- Having substantial concomitant cerebrovascular disease (defined by a history of a stroke
- / intracranial hemorrhage temporally related to the onset of worsening of cognitive impairment) per investigator judgement.
- Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.
- Medical history or diagnosis of any of the following symptomatic and unstable / uncontrolled conditions per investigator's judgement:
- Uncontrolled cardiovascular illnesses such as chronic congestive heart failure (with or without edema), tachycardia, arrhythmias, uncontrolled hypertension.
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- Significant ischemic heart disease, myocardial infarction within the last two years and/or with residual angina, orthopnea, conduction defects (ECG), or any other clinical significant heart disease classified as New York Heart Association (NYHA) III or IV.
- Significant gastrointestinal disorders (for example gastrointestinal bleeding within the last two years, malabsorption syndromes, post-gastrectomy, or active peptic ulcer disease).
- Uncontrolled endocrine disease such as uncontrolled diabetes mellitus or hyperthyroidism.
- Unstable/Uncontrolled major depression.
- Has neurological disease (other than dementia of Alzheimer's type, such as: Lewy body dementia - primary diagnosis, Huntington's disease, Parkinson's Disease, encephalitis, epilepsy, vascular or multiinfarct dementia, stroke, congenital mental deficiency, multiple sclerosis).
- Significant pulmonary disease predisposing to hypoxia.
- Has major physical illnesses (e.g. brain tumor, craniocerebral trauma, thyroid disease)
- Any other psychiatric disorders such as schizophrenia, or mental retardation.
- Any suicidal actions in the past 2 years (per investigator judgement i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior).
- Hachinski Ischemic Score > 4
- Significant history of drug dependence or abuse (including alcohol, as defined in Diagnostic and Statistical Manual of Mental Disorders [DSM-V] or in the opinion of the investigator)
- Clinically significant uncompensated hearing loss in the judgment of the investigator. Use of hearing aids is allowed.
- Has other condition(s) that in the opinions of investigators to be ineligible to participate in this study, e.g. Subject who cannot swallow the capsule whole.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Pei-Ling Peng, 886-2-23123456 ext. 65340, ho-ling@yahoo.com.tw
About this study
Official title: A Phase 2, Randomized, Double Blind, Placebo-Controlled Study of Oral EX039 As Add-on to Acetylcholine Esterase Inhibitors in Subjects with Mild Alzheimer's Disease
This is a phase 2, randomized, double-blind, placebo-controlled study of oral EX039 as add-on to Acetylcholine Esterase Inhibitors in subjects with mild Alzheimer's disease.
- Conditions
- Alzheimer Disease
- Being tested
- EX039, 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.
EX039Drug
The dosage form of EX039 is the capsule for oral use
PlaceboDrug
The dosage form of Placebo is the capsule for oral use
| Study group | Role | What they receive |
|---|---|---|
| 1000 mg | Experimental | The recruited patient randomly assigned to this arm will take 1000 mg EX039 per day Receives: Drug: EX039 |
| 750 mg | Experimental | The recruited patient randomly assigned to this arm will take 750 mg EX039 per day Receives: Drug: EX039 |
| placebo | Placebo comparator | The recruited patient randomly assigned to this arm will take placebo per day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alzheimer's Disease Assessment Scale-cognitive
Mean change from baseline in Alzheimer's Disease Assessment Scale-cognitive subscale measured at the end of week 28. Total scores range from 0-70, with higher scores (≥ 18) indicating greater cognitive impairment.
Measured: Week 28
Change in Clinical Dementia Rating-Sum of Boxes
Mean change from baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB). measured at the end of week 28. Total scores range from 0 to 18, with higher scores indicating more worsening.
Measured: Week 28
Secondary outcomes (3)
Change in Clinician's Interview-Based Impression of Change Plus Caregiver Input
Scorings of Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus) at the end of week 4, 12, 20, and 28.
Measured: Week 4, 12, 20, 28
Incidence of Treatment-Emergent Adverse Events
To assess the safety and tolerability of EX039
Measured: Week 30
Responder rate assessment
The percentage of the recruited subjects whose mean change from baseline in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) measured at the end of week 28 is improved (≧4) without deterioration of CDR-SB and CIBIS-Plus
Measured: Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start8 Aug 2022
- Primary completion31 Dec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Excelsior
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Formosa Biomedical Technology Corp.
- Responsible party
- Sponsor
- Investigators
- Ching-Kuan Liu, Dr., Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413655
- Sponsor's protocol ID
- EX-039-10701
- Status last verified
- Feb 2025
- First submitted
- 14 Mar 2022
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There won't be any individual participant data shared to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double Blind, Placebo-Controlled Study of Oral EX039 As Add-on to Acetylcholine Esterase Inhibitors in Subjects with Mild Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05413655
- Acronym / sponsor ID
- EX-039-10701
- Conditions
- Alzheimer Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- ExcelsiorIndustry (pharma, biotech, devices)
- Collaborators
- Formosa Biomedical Technology Corp.
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 10 Jun 2022 (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 is a phase 2, randomized, double-blind, placebo-controlled study of oral EX039 as add-on to Acetylcholine Esterase Inhibitors in subjects with mild 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
- 3
| Arm | Type | Receives |
|---|---|---|
| 1000 mg | Experimental | Drug: EX039The recruited patient randomly assigned to this arm will take 1000 mg EX039 per day |
| 750 mg | Experimental | Drug: EX039The recruited patient randomly assigned to this arm will take 750 mg EX039 per day |
| placebo | Placebo comparator | Drug: PlaceboThe recruited patient randomly assigned to this arm will take placebo per day |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Aged 50-80 years.
- Clinical diagnosis of probable mild Alzheimer disease dementia based on National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA criteria, 2011)
- Last time (which must be within 3 months ) of Mini Mental State Exam (MMSE) between 10-26.
- Last time (which must be within 3 months) of Clinical Dementia Rating (CDR) score of 1.
- Physically healthy and all laboratory assessments (including hematology, chemistry, urinalysis and electrocardiograph) are within normal range or meet the following criteria:
Key exclusion criteria (19 listed)
- Having other causes of dementia.
- Having substantial concomitant cerebrovascular disease (defined by a history of a stroke
- / intracranial hemorrhage temporally related to the onset of worsening of cognitive impairment) per investigator judgement.
- Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.
- Medical history or diagnosis of any of the following symptomatic and unstable / uncontrolled conditions per investigator's judgement:
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 |
|---|---|---|
| EX039The dosage form of EX039 is the capsule for oral use | Drug | 1000 mg, 750 mg |
| PlaceboThe dosage form of Placebo is the capsule for oral use | Drug | placebo |
Primary outcome
Change in Alzheimer's Disease Assessment Scale-cognitive
Time frame: Week 28
Mean change from baseline in Alzheimer's Disease Assessment Scale-cognitive subscale measured at the end of week 28. Total scores range from 0-70, with higher scores (≥ 18) indicating greater cognitive impairment.
Change in Clinical Dementia Rating-Sum of Boxes
Time frame: Week 28
Mean change from baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB). measured at the end of week 28. Total scores range from 0 to 18, with higher scores indicating more worsening.
3 secondary outcomes
Change in Clinician's Interview-Based Impression of Change Plus Caregiver Input
Time frame: Week 4, 12, 20, 28
Incidence of Treatment-Emergent Adverse Events
Time frame: Week 30
Responder rate assessment
Time frame: Week 28
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 26 Feb 2025.
- Individual participant dataSharing planned: No. There won't be any individual participant data shared to other researchers.
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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.
Ching-Kuan Liu, Dr. principal investigator
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EX039 in people with Alzheimer Disease, run by Excelsior at 1 site in Taiwan.
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 14 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 26 Feb 2025. 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 Taiwan. 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?
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 Cliff Lin (+886-972821234, cliff.lin@excelsiorgroup.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Alzheimer's Disease Assessment Scale-cognitive (time frame: Week 28). The study lists 2 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 26 Feb 2025.