Alzheimer DiseasePhase 2NCT07905352
A Phase 2 Clinical Study of Simenafil Hydrochloride Tablets in the Treatment of Alzheimer's Disease
A Phase 2 study testing Simenafil Hydrochloride Tablets 2.5 mg, Simenafil Hydrochloride Tablets 5 mg and Simenafil Hydrochloride Tablets 10 mg in people with Alzheimer Disease, run by Vigonvita Life Sciences at 1 site in China.
Trial summary
This study is a multicenter, randomized, double-Blind, placebo-controlled Phase 2 clinical study to evaluate the efficacy and safety of Simenafil Hydrochloride Tablets in the treatment of participants with Alzheimer's Disease Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Simenafil Hydrochloride Tablets 2.5 mg, Simenafil Hydrochloride Tablets 5 mg and Simenafil Hydrochloride Tablets 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Nov 2026to Dec 2028
- 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 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants aged 55 to 90 years of age inclusive at the time of signing the informed consent form.
- Mild cognitive impairment due to AD or mild AD dementia defined by stages 3 to 4 according to the National Institute on Aging and Alzheimer's Association (NIA-AA) 2024 diagnostic and staging criteria at Screening.
- At screening, participants show positive cerebral amyloid pathology on amyloid beta (Aβ) positron emission tomography (PET) imaging.
- Participants with a history of subjective cognitive and memory decline with onset within 5 years before Screening, confirmed by a relative, caregiver, or other informant familiar with their medical history.
- Participants who have a Mini-Mental State Examination (MMSE) score ≥ 20 at Screening.
- Participants who have a Clinical Dementia Rating-Global Score (CDR-GS) of 0.5 or 1, and a CDR memory box score ≥ 0.5 at Screening.
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- Participants must have a stable and reliable adult study partner. The study partner should have known the participant for at least 1 year, maintain frequent and adequate contact with the participant during the study (at least 4 days per week and at least 2 hours per day), be familiar with the participant's daily cognitive, functional, and living status, be able to understand the requirements of study participation, accompany the participant to all study visits, and provide reliable information for relevant scale assessments. The study partner should not be changed during the study whenever possible. The study partner voluntarily signs the informed consent form to participate as a study partner.
- From signing the informed consent form until 3 months after the last dose, women of childbearing potential (WOCBP) and male participants with female partners of childbearing potential agree to use effective contraception.
- Participants fully understand the purpose, content, and possible adverse reactions of this study, voluntarily participate in the clinical trial and sign the written informed consent form, and are able to complete the entire study process in accordance with study requirements and comply with study regulations.
Who cannot join
- Dementia due to other causes, including but not limited to vascular dementia, central nervous system infection, Creutzfeldt-Jakob disease, Huntington's disease, Parkinson's disease, dementia with Lewy bodies, frontotemporal dementia, post-traumatic dementia, other physical or chemical factors (e.g., drug intoxication, alcohol intoxication, carbon monoxide poisoning), major somatic diseases (e.g., hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial space-occupying lesions (e.g., subdural hematoma, brain tumors), endocrine disorders (e.g., thyroid disease), or vitamin B12 or folate deficiency, or dementia due to any other known cause.
- Significant focal lesions shown on MRI within 3 months prior to screening or at screening, meeting any of the following: 1) more than 2 infarcts with a diameter greater than 2 cm; 2) infarcts in key regions such as the thalamus, hippocampus, entorhinal cortex, perirhinal cortex, angular gyrus, and other cortical and subcortical gray matter nuclei; 3) white matter damage with a Fazekas Scale grade ≥ 3. Focal lesions judged by the investigator not to affect cognition or function are excepted.
- Participants with a psychiatric disorder diagnosed by a psychiatrist that, in the investigator's judgment, may confound the interpretation of the drug effect, affect cognitive assessments, or affect the participant's ability to complete the study, including but not limited to schizophrenia, bipolar I disorder, bipolar II disorder, major depressive disorder, delirium, etc.
- Participants with central nervous system diseases, including but not limited to stroke, neuromyelitis optica, Parkinson's disease, epilepsy, etc.
- Participants with a Geriatric Depression Scale 15-item (GDS-15) score ≥ 8 at Screening.
- Based on the investigator's assessment and the Columbia-Suicide Severity Rating Scale (C-SSRS), participants who had suicidal intent within 6 months prior to screening or are at risk of impulsive behavior or suicide during the study, i.e., those who answer "yes" to item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) of the C-SSRS "suicidal ideation" items, or who have had an actual suicide attempt within the past 1 year. Non-suicidal self-injurious behavior within the past 1 year does not constitute an exclusion criterion; however, if the investigator clinically assesses that the participant currently has a significant risk of self-injury, the participant should still be excluded.
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- Participants with a history of drug abuse or illicit drug use within 1 year prior to screening.
- Participants with hereditary degenerative retinal diseases such as retinitis pigmentosa, or a history of non-arteritic anterior ischemic optic neuropathy (NAION), or other serious ocular diseases that, in the investigator's judgment, may affect the participant's safety assessment, completion of scales, or study compliance.
- Participants with known allergy to any component of simenafil hydrochloride tablets or the placebo, or a history of allergy to phosphodiesterase type 5 (PDE5) inhibitors.
- Participants who have a contraindication to PET or MRI in the Investigator's judgment. Note: MRI contraindication applies only to participants who are required to undergo the corresponding examination.
- Participants with a history of myocardial infarction, unstable angina, coronary artery disease and/or New York Heart Association (NYHA) class III or IV heart failure within 1 year prior to screening.
- Participants with a history of cancer or malignancy within 5 years prior to screening, except for the following:
- Basal or squamous cell carcinoma of the skin or cervical cell dysplasia that has been adequately treated.
- Stage 1 cervical carcinoma in situ that has been completely treated for at least 2 years prior to screening, with no recurrence.
- Prostate cancer confined to the prostate that has been adequately treated (e.g., surgery and/or radiotherapy, or watchful waiting), with normal or low prostate-specific antigen (PSA) levels that have remained stable for at least 2 years prior to screening; where necessary, relevant examinations will be performed at the investigator's discretion.
- Non-metastatic breast cancer that has been adequately treated.
- Participants with uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 95 mmHg) or hypotension (systolic blood pressure < 90 mmHg or diastolic blood pressure < 60 mmHg).
- Participants meet any of the following:
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin > 2.5 × the upper limit of normal (any one).
- Vitamin B12 < the lower limit of normal.
- Known history of human immunodeficiency virus (HIV) positivity, or positive HIV 1/2 test at screening.
- Positive hepatitis B virus surface antigen (HBsAg) test.
- Known history of hepatitis C virus (HCV), or positive HCV antibody (HCVAb) test at screening (unless confirmatory PCR is negative).
- Known history of neurosyphilis, or positive Treponema pallidum specific antibody (TP Ab) at screening.
- Participants who are using a cholinesterase inhibitor and/or memantine at Screening but have been receiving stable-dose treatment for less than 3 months.
- Participants who have a history of, or are receiving at Screening, anti-amyloid therapy, anti-tau therapy, or any investigational treatment for Alzheimer's disease.
- Participants who have used the following prohibited medications prior to randomization without meeting the corresponding washout period requirements (if the same drug falls under multiple prohibited categories, the longer prohibition period shall apply), or who are expected to require concomitant use of the following prohibited medications during the study:
- Other PDE5 inhibitors, with a washout period of at least 5 half-lives (of the prohibited drug) prior to randomization;
- Nitrates, nitric oxide (NO) donors, soluble guanylate cyclase stimulators, or alpha-blockers, with a washout period of at least 5 half-lives (of the prohibited drug) prior to randomization;
- Strong CYP3A4 inhibitors, moderate CYP3A4 inhibitors, strong CYP3A4 inducers, or moderate CYP3A4 inducers, with a washout period of at least 30 days prior to randomization, except for topical use.
- Participants who have participated in any drug or device clinical trial and received investigational drug or device within 3 months prior to Screening, or who are currently participating in another clinical trial.
- Female participants who are lactating, or female participants of childbearing potential with a positive pregnancy test.
- Participants with any other factors that make them unsuitable for participation in the study, in the investigator's judgment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xuanwu Hospital ,Capital Medical University
Beijing, Beijing Municipality
Yi Tang
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study to Evaluate the Efficacy and Safety of Simenafil Hydrochloride Tablets in the Treatment of Alzheimer's Disease
This study is a multicenter, randomized, double-Blind, placebo-controlled Phase 2 clinical study to evaluate the efficacy and safety of Simenafil Hydrochloride Tablets in the treatment of participants with Alzheimer's Disease
Read the detailed description
This study initially plans to enroll 200 participants, who will be randomized in a 1:1:1:1 ratio to receive simenafil hydrochloride tablets 2.5 mg, 5 mg, 10 mg, or placebo, with 50 participants in each group.Participants will receive the study drug once daily for 52 consecutive weeks of treatment.
- Conditions
- Alzheimer Disease
- Being tested
- Simenafil Hydrochloride Tablets 2.5 mg, Simenafil Hydrochloride Tablets 5 mg, Simenafil Hydrochloride Tablets 10 mg, Placebo Tablets
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simenafil Hydrochloride Tablets 2.5 mgDrug
Also called Low-dose group
Simenafil Hydrochloride Tablets 1 tablet (2.5mg/tablet) + Simenafil Hydrochloride Tablets placebo 1 tablet (10mg/tablet)
Simenafil Hydrochloride Tablets 5 mgDrug
Also called Medium-dose group
Simenafil Hydrochloride Tablets 1 tablet (5mg/tablet) + Simenafil Hydrochloride Tablets placebo 1 tablet (10mg/tablet)
Simenafil Hydrochloride Tablets 10 mgDrug
Also called High-dose group
Simenafil Hydrochloride Tablets 1 tablet (10mg/tablet) + Simenafil Hydrochloride Tablets placebo 1 tablet (5mg/tablet)
Placebo TabletsDrug
Also called Placebo Comparator
Simenafil Hydrochloride Tablets placebo 1 tablet (5mg/tablet) + Simenafil Hydrochloride Tablets placebo 1 tablet (10mg/tablet)
| Study group | Role | What they receive |
|---|---|---|
| Simenafil Hydrochloride Tablets | Experimental | 2.5 mg/5 mg /10 mg, administered orally once daily for 52consecutive weeks Receives: Drug: Simenafil Hydrochloride Tablets 2.5 mg; Drug: Simenafil Hydrochloride Tablets 5 mg; Drug: Simenafil Hydrochloride Tablets 10 mg |
| Placebo Tablet | Placebo comparator | Administered orally once daily for 52 consecutive weeks Receives: Drug: Placebo Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)
Change from baseline in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) total score at Week 26 and Week 52. Possible scores range from 0 to 18; higher scores represent greater dementia impairment (worse outcome).
Measured: 52 Weeks
Secondary outcomes (14)
Alzheimer's Disease Assessment Scale-Cognitive Subscale 13-item (ADAS-Cog13)
Change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale 13-item (ADAS-Cog13) score at Week 26 and Week 52. Possible scores range from 0 to 85; higher scores represent worse cognitive function (worse outcome).
Measured: 52 Weeks
Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)
Change from baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) score at Week 26 and Week 52. Possible scores range from 0 to 78; higher scores represent better daily function (better outcome).
Measured: 52 Weeks
15-item Geriatric Depression Scale (GDS-15)
Change from baseline in the 15-item Geriatric Depression Scale (GDS-15) score at Week 26 and Week 52. Possible scores range from 0 to 15; higher scores represent more severe depressive symptoms (worse outcome).
Measured: 52 Weeks
Mini-Mental State Examination (MMSE)
Change from baseline in the Mini-Mental State Examination (MMSE) score at Week 26 and Week 52. Possible scores range from 0 to 30; higher scores represent better global cognitive function (better outcome).
Measured: 52 Weeks
Plasma p-tau181
Change from baseline in plasma p-tau181 concentration at Week 26 and Week 52.
Measured: 52 Weeks
Plasma p-tau217
Change from baseline in plasma p-tau217 concentration at Week 26 and Week 52.
Measured: 52 Weeks
Plasma p-tau231
Change from baseline in plasma p-tau231 concentration at Week 26 and Week 52.
Measured: 52 Weeks
Plasma Aβ42
Change from baseline in plasma Aβ42 concentration at Week 26 and Week 52.
Measured: 52 Weeks.
Plasma Aβ40
Change from baseline in plasma Aβ40 concentration at Week 26 and Week 52.
Measured: 52 Weeks
Plasma Aβ42/Aβ40 Ratio
Change from baseline in plasma Aβ42/Aβ40 ratio at Week 26 and Week 52.
Measured: 52 Weeks
Plasma Glial Fibrillary Acidic Protein (GFAP)
Change from baseline in plasma Glial Fibrillary Acidic Protein (GFAP) concentration at Week 26 and Week 52.
Measured: 52 Weeks
Plasma Neurofilament Light Chain (NfL)
Change from baseline in plasma Neurofilament Light Chain (NfL) concentration at Week 26 and Week 52.
Measured: 52 Weeks
Brain Aβ-PET Centiloid (CL)
Change from baseline in brain amyloid-beta PET quantified Centiloid (CL) value at Week 26 and Week 52. Higher Centiloid values indicate greater amyloid-beta burden (worse amyloid pathology).
Measured: 52 Weeks
Adverse Events (AEs) and Serious Adverse Events (SAE
Incidence, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs) from baseline through Week 52.
Measured: 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (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.
- More trials run by Vigonvita Life SciencesThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vigonvita Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yi Tang, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905352
- Sponsor's protocol ID
- TPN171-AD-II-01
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study to Evaluate the Efficacy and Safety of Simenafil Hydrochloride Tablets in the Treatment of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07905352
- Acronym / sponsor ID
- TPN171-AD-II-01
- Conditions
- Alzheimer Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Vigonvita Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 29 Oct 2026 (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 a multicenter, randomized, double-Blind, placebo-controlled Phase 2 clinical study to evaluate the efficacy and safety of Simenafil Hydrochloride Tablets in the treatment of participants with Alzheimer's Disease
Detailed description
This study initially plans to enroll 200 participants, who will be randomized in a 1:1:1:1 ratio to receive simenafil hydrochloride tablets 2.5 mg, 5 mg, 10 mg, or placebo, with 50 participants in each group.Participants will receive the study drug once daily for 52 consecutive weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simenafil Hydrochloride Tablets | Experimental | Drug: Simenafil Hydrochloride Tablets 2.5 mg, Drug: Simenafil Hydrochloride Tablets 5 mg, Drug: Simenafil Hydrochloride Tablets 10 mg2.5 mg/5 mg /10 mg, administered orally once daily for 52consecutive weeks |
| Placebo Tablet | Placebo comparator | Drug: Placebo TabletsAdministered orally once daily for 52 consecutive weeks |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female participants aged 55 to 90 years of age inclusive at the time of signing the informed consent form.
- Mild cognitive impairment due to AD or mild AD dementia defined by stages 3 to 4 according to the National Institute on Aging and Alzheimer's Association (NIA-AA) 2024 diagnostic and staging criteria at Screening.
- At screening, participants show positive cerebral amyloid pathology on amyloid beta (Aβ) positron emission tomography (PET) imaging.
- Participants with a history of subjective cognitive and memory decline with onset within 5 years before Screening, confirmed by a relative, caregiver, or other informant familiar with their medical history.
- Participants who have a Mini-Mental State Examination (MMSE) score ≥ 20 at Screening.
Key exclusion criteria (33 listed)
- Dementia due to other causes, including but not limited to vascular dementia, central nervous system infection, Creutzfeldt-Jakob disease, Huntington's disease, Parkinson's disease, dementia with Lewy bodies, frontotemporal dementia, post-traumatic dementia, other physical or chemical factors (e.g., drug intoxication, alcohol intoxication, carbon monoxide poisoning), major somatic diseases (e.g., hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial space-occupying lesions (e.g., subdural hematoma, brain tumors), endocrine disorders (e.g., thyroid disease), or vitamin B12 or folate deficiency, or dementia due to any other known cause.
- Significant focal lesions shown on MRI within 3 months prior to screening or at screening, meeting any of the following: 1) more than 2 infarcts with a diameter greater than 2 cm; 2) infarcts in key regions such as the thalamus, hippocampus, entorhinal cortex, perirhinal cortex, angular gyrus, and other cortical and subcortical gray matter nuclei; 3) white matter damage with a Fazekas Scale grade ≥ 3. Focal lesions judged by the investigator not to affect cognition or function are excepted.
- Participants with a psychiatric disorder diagnosed by a psychiatrist that, in the investigator's judgment, may confound the interpretation of the drug effect, affect cognitive assessments, or affect the participant's ability to complete the study, including but not limited to schizophrenia, bipolar I disorder, bipolar II disorder, major depressive disorder, delirium, etc.
- Participants with central nervous system diseases, including but not limited to stroke, neuromyelitis optica, Parkinson's disease, epilepsy, etc.
- Participants with a Geriatric Depression Scale 15-item (GDS-15) score ≥ 8 at Screening.
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 |
|---|---|---|
| Simenafil Hydrochloride Tablets 2.5 mgAlso: Low-dose groupSimenafil Hydrochloride Tablets 1 tablet (2.5mg/tablet) + Simenafil Hydrochloride Tablets placebo 1 tablet (10mg/tablet) | Drug | Simenafil Hydrochloride Tablets |
| Simenafil Hydrochloride Tablets 5 mgAlso: Medium-dose groupSimenafil Hydrochloride Tablets 1 tablet (5mg/tablet) + Simenafil Hydrochloride Tablets placebo 1 tablet (10mg/tablet) | Drug | Simenafil Hydrochloride Tablets |
| Simenafil Hydrochloride Tablets 10 mgAlso: High-dose groupSimenafil Hydrochloride Tablets 1 tablet (10mg/tablet) + Simenafil Hydrochloride Tablets placebo 1 tablet (5mg/tablet) | Drug | Simenafil Hydrochloride Tablets |
| Placebo TabletsAlso: Placebo ComparatorSimenafil Hydrochloride Tablets placebo 1 tablet (5mg/tablet) + Simenafil Hydrochloride Tablets placebo 1 tablet (10mg/tablet) | Drug | Placebo Tablet |
Primary outcome
Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)
Time frame: 52 Weeks
Change from baseline in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) total score at Week 26 and Week 52. Possible scores range from 0 to 18; higher scores represent greater dementia impairment (worse outcome).
14 secondary outcomes
Alzheimer's Disease Assessment Scale-Cognitive Subscale 13-item (ADAS-Cog13)
Time frame: 52 Weeks
Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)
Time frame: 52 Weeks
15-item Geriatric Depression Scale (GDS-15)
Time frame: 52 Weeks
Mini-Mental State Examination (MMSE)
Time frame: 52 Weeks
Plasma p-tau181
Time frame: 52 Weeks
Plasma p-tau217
Time frame: 52 Weeks
Plasma p-tau231
Time frame: 52 Weeks
Plasma Aβ42
Time frame: 52 Weeks.
Plasma Aβ40
Time frame: 52 Weeks
Plasma Aβ42/Aβ40 Ratio
Time frame: 52 Weeks
Plasma Glial Fibrillary Acidic Protein (GFAP)
Time frame: 52 Weeks
Plasma Neurofilament Light Chain (NfL)
Time frame: 52 Weeks
Brain Aβ-PET Centiloid (CL)
Time frame: 52 Weeks
Adverse Events (AEs) and Serious Adverse Events (SAE
Time frame: 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 29 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Yi Tang principal investigator
Xuanwu Hospital, Beijing
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 Simenafil Hydrochloride Tablets 2.5 mg, Simenafil Hydrochloride Tablets 5 mg and Simenafil Hydrochloride Tablets 10 mg in people with Alzheimer Disease, run by Vigonvita Life Sciences at 1 site in China.
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 9 inclusion and 33 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 29 Oct 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 China. 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 Huaqing Duan (+8618061926005, huaqing.duan@vigonvita.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) (time frame: 52 Weeks). 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 29 Oct 2026.