Mild Cognitive ImpairmentPhase 2SenicapocNCT04804241
Senicapoc in Alzheimer's Disease
A Phase 2 study testing Senicapoc in people with Mild Cognitive Impairment and Alzheimer Disease, run by University of California, Davis at 2 sites in United States.
Trial summary
Development of novel disease-modifying therapies for Alzheimer's disease (AD) remains of paramount importance. This study will be a Phase II randomized clinical trial testing Senicapoc in patients with mild or prodromal AD. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease
- What is being tested?
- Senicapoc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Mar 2022to Dec 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 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 55-85
- Fluent in either English or Spanish
- Willing to be randomized to active drug (10 mg Senicapoc) vs. placebo (3:1 ratio)
- Clinical Dementia Rating (CDR) global score of 1 or 0.5
- Education adjusted scores between 12-28 on the Montreal Cognitive Assessment (MoCA) at the Screening visit.
- A consensus clinical diagnosis of either amnestic Mild Cognitive Impairment (MCI) or mild AD dementia. Diagnoses are made by a comprehensive case conference review for all participants in the ADRC longitudinal cohort and all CADC referrals, resulting in a consensus diagnosis made according to current research criteria. For patients referred from other clinics, the case will be reviewed by a study physician and neuropsychologist and only patients who satisfy criteria for probable AD (McKhann et al 1984) or amnestic MCI (Petersen et al 2004) will be eligible for enrollment.
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- Vision (with or without correction) of at least 20/50 for distant vision
- All participants will need a study partner informant who has at least 6 hours of contact per week with the participant. The study partners are used to help answer questions on the subject's behalf, since many of them will be impaired and may need assistance with providing accurate information. The study partners are not asked to provide any opinions or judgements about the subjects.
- For Females of childbearing potential: Must agree to practice a highly effective method of contraception throughout the study until completion of the Week 78 follow up visit. Highly effective methods of contraception are those that alone or in combination result in a failure rate of less than 1% per year when used correctly and consistently.
Who cannot join
- Unstable medical illnesses including hepatic insufficiency (elevated ALT, AST, or GGT; or low albumin attributable to liver disease), renal insufficiency (CK-EPI stage 4 or higher, or estimated GFR <30)
- Unstable ischemic cardiovascular disease, respiratory failure, moderate or severe congestive heart failure - New York Heart Association class III or IV, cancer, unstable hematologic disease or a life expectancy of <3 years
- Use of experimental AD treatments
- Unable to undergo MRI scanning (e.g. pacemaker, metallic implants, severe claustrophobia)
- History of chronic psychiatric illness (e.g. schizophrenia), any episode of major depression within last 2 years, or current Geriatric Depression Scale (GDS) > 6, any recent suicide attempts or suicidal ideation. Subjects with a diagnosis of bipolar disorder may be included if they have been clinically stable for a minimum of 3 years prior to the Screening visit. Clinical stability to be determined by the Principal Investigator.
- History of a serious infectious disease affecting the brain (including neurosyphilis, meningitis, or encephalitis), head trauma resulting in any persistent cognitive deficit
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- History of alcohol or drug abuse/dependence within the past 5 years
- Known allergy to chemically related compounds (e.g. clotrimazole)
- Lack of good venous access, such that multiple blood draws would be precluded
- Regular use of any of these CNS active medications: benzodiazepines, antipsychotics, narcotics, or anti-epileptic drugs. Exceptions may be allowed by the Principal Investigator for regular use of low doses of CNS active medications. Subjects using any of these treatments will be instructed to hold their dose on the evening prior and the day of the efficacy visits (Baseline, Week 26 and Week 52). Stable doses (> 6 weeks) of cholinesterase inhibitors or memantine will be allowed, as will stable doses of anti-depressants.
- Female subjects who are pregnant or breastfeeding or who plan to become pregnant during participation in this trial
- Inability to swallow oral tablets
- Exclusions for Cerebrospinal Fluid (CSF) Sub-study:
- Presence of an implanted shunt for the drainage of CSF or an implanted CNS catheter
- History of bleeding diathesis or coagulopathy,
- On anticoagulant therapy (within 14 days of lumbar puncture (LP), including but not limited to warfarin, heparin, dabigatran, rivaroxaban, and apixaban,
- Requires daily antiplatelet therapy, including but not limited to aspirin (unless < 81mg/day), clopidogrel, dipyridamole, and ticlopiidinegrel. However, the investigators will not exclude those who can safely hold antiplatelet therapy for 7 days prior to LP. Safety will be determined by the participant's Primary Care Provider and study PI.
- For those who take antiplatelet therapy intermittently (e.g. aspirin as needed for pain), the investigators will exclude any doses within 48 hours of the LP or more than two dosses within 7 days of LP.
- platelet count less than the lower limit of normal (platelet counts between 100,000 and 150,000 mm3 are permissible as long as the investigator confirms there is no evidence of current bleeding diathesis or coagulopathy)
- The investigators will require INR/PT and aPTT labs to be done within 14 days of LP and will exclude those with INR > 1.30 or abnormally elevated aPTT.
- Exclusions for PET Sub-Study:
- Does not have good venous access, such that multiple blood draws would be precluded
- Prior radiation exposure of > 2 rem total within last 12 months.
- Probable AD dementia patients with a global cortical SUVr < 1.08.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of California, Davis Alzheimer's Disease Center
Sacramento, California, 95817
Martha Forloines, PhD, 916-734-5223, mrforloines@ucdavis.edu
- Recruiting
UC Davis Alzheimer's Disease Center East Bay
Walnut Creek, California, 94598
Martha Forloines, PhD, 916-734-5223, mrforloines@ucdavis.edu
About this study
Official title: Proof of Mechanism Study of Senicapoc in Mild or Prodromal Alzheimer's Disease
Development of novel disease-modifying therapies for Alzheimer's disease (AD) remains of paramount importance. This study will be a Phase II randomized clinical trial testing Senicapoc in patients with mild or prodromal AD. This will be a small Proof of Mechanism study to prove biological activity and target engagement in humans with early AD. The investigators will study up to 55 patients over 52 weeks, with primary outcomes being Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) scores and blood and cerebrospinal fluid (CSF) markers of neuroinflammation. This pilot study will provide an estimate of treatment effect size on cognitive trajectory, daily function, and brain atrophy.
Read the detailed description
The investigators will study up to 55 patients (8:3 active treatment with 10 mg/day maintenance dose: placebo) over 52 weeks in either the Sacramento or East Bay locations the University of California Davis Alzheimer's Disease Research Center (ADRC), with cognitive outcomes, blood, and CSF markers of neuroinflammation. This pilot study will provide an estimate of treatment effect size on cognitive trajectory, daily function, and brain atrophy. The trial will last 1 year (52 weeks on 10 mg/day of active drug or placebo) with primary efficacy measures at baseline, week 26, and week 52. Additional safety monitoring visits will occur at weeks 4, 12, and 36 including physical exams, measurement of blood pressure, vital signs, safety labs, electrocardiogram recordings, collection of Adverse Events and Concomitant Medications. The study will culminate with a visit at 78 weeks (26 weeks after last dose, allowing full wash-out from the central nervous system (CNS)) to test if the previously treated and untreated groups show any differences, as would be expected if Senicapoc treatment for 1 year was disease-modifying. All participants will be required to participate in either the CSF Sub-study or the Amyloid Positron Emission Tomography (PET) Sub-study. All participants will be required to participate in the Cognitive Event Related Potential (ERP) Sub-study.
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Being tested
- Senicapoc, Placebo Tablet
- Keywords
- Amnestic Mild Cognitive Impairment (MCI), Mild AD dementia, Senicapoc
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SenicapocDrug
Also called TRAM-34
10 mg oral tablet
Placebo TabletOther
Placebo Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| 10 mg daily Senicapoc | Experimental | 10 mg daily Senicapoc for 52 weeks Receives: Drug: Senicapoc |
| Placebo Group | Placebo comparator | Placebo daily for 52 weeks Receives: Other: Placebo Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog 13) score
ADAS-Cog 13 is a scale used to measure cognitive dysfunction in a number of neural domains. Total scores range from 0-70, with higher scores indicating greater cognitive impairment and a worse outcome.
Measured: Baseline, Week 26, Week 52
Change from Baseline to Week 52 in levels of Cerebrospinal fluid (CSF) biomarkers: IL-1β, IL-6, TNF-α, MCP-1, and IL-10
A lumbar puncture will be done and CSF collected at baseline prior to initiating study treatment and at Week 52 at the end of study treatment
Measured: Baseline, Week 52
Change from Baseline to Week 52 in levels of serum biomarkers: IL-6, TNF-α, MCP-1, and IL-10 and high sensitivity C-Reactive protein
Blood draws will be done and serum processed at baseline prior to initiating study treatment and at Week 52 at the end of study treatment
Measured: Baseline, Week 52
Secondary outcomes (16)
Change from Screening in the Clinical Dementia Rating (CDR) sum of boxes score
The CDR is a widely used clinical tool for grading the relative severity of dementia with scores that range from 0 (no impairment) to 3 (severe impairment). A higher score indicates greater cognitive impairment and a worse outcome.
Measured: Screening, Week 26, Week 52
Change from Baseline in the Everyday Cognition (ECog) score
The ECog is a validated instrument used to assess cognitively mediated functional abilities in older adults. It is comprised of 39 items and a higher total score indicates greater cognitive impairment and a worse outcome.
Measured: Baseline, Week 26, Week 52
Change from Screening in Montreal Cognitive Assessment (MoCA) score
The MoCA is a diagnostic tool used for detecting Mild Cognitive Impairment and early Alzheimer's disease. The scale goes from 0 to 30. A higher score indicates less cognitive impairment and a better outcome.
Measured: Screening, Week 26, Week 52
Change from Baseline to Week 52 in Spanish English Neuropsychological Assessment Scales (SENAS) memory score
The SENAS was devised to be a broad set of psychometrically matched measures with equivalent Spanish and English versions. The composites are z-scores, the more positive the score is, the less cognitive impairment and the better the outcome.
Measured: Baseline, Week 52
Change from Baseline to Week 52 in Spanish English Neuropsychological Assessment Scales (SENAS) executive composite score
The SENAS was devised to be a broad set of psychometrically matched measures with equivalent Spanish and English versions. The composites are z-scores, the more positive the score is, the less cognitive impairment and the better the outcome.
Measured: Baseline, Week 52
Change from Baseline in Bushcke Cued Selective Reminding Task (CSRT) score
The CSRT is widely used to identify mild dementia and measure associative learning and memory. It involves a study phase where subjects identify pictured items in response to category cures. This is followed by a free recall period and then a cued recall period where category cues are presented to the subjects. The raw score for the CSRT is 0 to 48 (16 items with 3 recall trials). The combined scores when combining the Free plus Cued Recall trials is 0 to 96. The higher the score, the less cognitive impairment and the better the outcome.
Measured: Baseline, Week 26, Week 52
Change from Baseline in Trails B score
The Trails B is a well-established measure of executive function in which subjects must serially connect alternating numbers and letters. It is scored based on accuracy and time to completion. A longer time to complete indicates greater cognitive impairment and a worse outcome.
Measured: Baseline, Week 26, Week 52
Change from Baseline in Verbal fluency (semantic) score
Controlled Oral Word Association Test (COWAT) is a verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with some designated letter (e.g. Animals, Fruits, Vegetables, letter 'F', 'A', 'S'). The more words correctly stated by the participant for a particular category in a 1-minute time period indicates less cognitive impairment and a better outcome.
Measured: Baseline, Week 26, Week 52
Change from Baseline in Verbal fluency (letter) score
Controlled Oral Word Association Test (COWAT) is a verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with some designated letter (e.g. Animals, Fruits, Vegetables, letter 'F', 'A', 'S'). The more words correctly stated by the participant for a specific letter in a 1-minute time period, indicates less cognitive impairment and a better outcome.
Measured: Baseline, Week 26, Week 52
Change from Baseline to Week 52 in Brain MRI measures of total grey matter.
Volumetric MRIs will be done at baseline and Week 52.
Measured: Baseline, Week 52
Change from Baseline to Week 52 in Brain MRI measures of total brain volume.
Volumetric MRIs will be done at baseline and Week 52.
Measured: Baseline, Week 52
Change from Baseline to Week 52 in Brain MRI measures of white matter hyperintensities.
Volumetric MRIs will be done at baseline and Week 52.
Measured: Baseline, Week 52
Change from Baseline to Week 52 in total grey matter florbetaben binding on amyloid Positron Emission Tomography (PET)
Amyloid PETs will be done at baseline and Week 52.
Measured: Baseline, Week 52
Change from Baseline in Cognitive Event Related Potential (ERP) measures of P600 word repetition.
Cognitive ERPs will be done at Baseline, Week 26 and Week 52
Measured: Baseline, Week 26, Week 52
Change from Baseline in Cognitive Event Related Potential (ERP) measures of alpha suppression effect.
Cognitive ERPs will be done at Baseline, Week 26 and Week 52
Measured: Baseline, Week 26, Week 52
Change from Baseline in Cognitive Event Related Potential (ERP) measures of anti-coupling between early theta and late alpha/beta activity.
Cognitive ERPs will be done at Baseline, Week 26 and Week 52
Measured: Baseline, Week 26, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start18 Mar 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized 3 to 1 to receive active study medication versus placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Drug Discovery Foundation, Alzheimer's Association, Biossil Inc.
- Responsible party
- Sponsor
- Investigators
- John Olichney, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804241
- Sponsor's protocol ID
- 945869
- Acronym
- Senicapoc
- Status last verified
- Aug 2026
- First submitted
- 7 Mar 2021
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigator may share individual participant data collected, after de-identification, that supports the results reported in published articles (test, tables, figures, appendices)
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Mechanism Study of Senicapoc in Mild or Prodromal Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04804241
- Acronym / sponsor ID
- Senicapoc / 945869
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Keywords
- Amnestic Mild Cognitive Impairment (MCI), Mild AD dementia, Senicapoc
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Alzheimer's Drug Discovery Foundation, Alzheimer's Association, Biossil Inc.
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Mar 2021 (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.
Development of novel disease-modifying therapies for Alzheimer's disease (AD) remains of paramount importance. This study will be a Phase II randomized clinical trial testing Senicapoc in patients with mild or prodromal AD. This will be a small Proof of Mechanism study to prove biological activity and target engagement in humans with early AD. The investigators will study up to 55 patients over 52 weeks, with primary outcomes being Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) scores and blood and cerebrospinal fluid (CSF) markers of neuroinflammation. This pilot study will provide an estimate of treatment effect size on cognitive trajectory, daily function, and brain atrophy.
Detailed description
The investigators will study up to 55 patients (8:3 active treatment with 10 mg/day maintenance dose: placebo) over 52 weeks in either the Sacramento or East Bay locations the University of California Davis Alzheimer's Disease Research Center (ADRC), with cognitive outcomes, blood, and CSF markers of neuroinflammation. This pilot study will provide an estimate of treatment effect size on cognitive trajectory, daily function, and brain atrophy. The trial will last 1 year (52 weeks on 10 mg/day of active drug or placebo) with primary efficacy measures at baseline, week 26, and week 52. Additional safety monitoring visits will occur at weeks 4, 12, and 36 including physical exams, measurement of blood pressure, vital signs, safety labs, electrocardiogram recordings, collection of Adverse Events and Concomitant Medications. The study will culminate with a visit at 78 weeks (26 weeks after last dose, allowing full wash-out from the central nervous system (CNS)) to test if the previously treated and untreated groups show any differences, as would be expected if Senicapoc treatment for 1 year was disease-modifying. All participants will be required to participate in either the CSF Sub-study or the Amyloid Positron Emission Tomography (PET) Sub-study. All participants will be required to participate in the Cognitive Event Related Potential (ERP) Sub-study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized 3 to 1 to receive active study medication versus placebo.
| Arm | Type | Receives |
|---|---|---|
| 10 mg daily Senicapoc | Experimental | Drug: Senicapoc10 mg daily Senicapoc for 52 weeks |
| Placebo Group | Placebo comparator | Other: Placebo TabletPlacebo daily for 52 weeks |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 55-85
- Fluent in either English or Spanish
- Willing to be randomized to active drug (10 mg Senicapoc) vs. placebo (3:1 ratio)
- Clinical Dementia Rating (CDR) global score of 1 or 0.5
- Education adjusted scores between 12-28 on the Montreal Cognitive Assessment (MoCA) at the Screening visit.
Key exclusion criteria (24 listed)
- Unstable medical illnesses including hepatic insufficiency (elevated ALT, AST, or GGT; or low albumin attributable to liver disease), renal insufficiency (CK-EPI stage 4 or higher, or estimated GFR <30)
- Unstable ischemic cardiovascular disease, respiratory failure, moderate or severe congestive heart failure - New York Heart Association class III or IV, cancer, unstable hematologic disease or a life expectancy of <3 years
- Use of experimental AD treatments
- Unable to undergo MRI scanning (e.g. pacemaker, metallic implants, severe claustrophobia)
- History of chronic psychiatric illness (e.g. schizophrenia), any episode of major depression within last 2 years, or current Geriatric Depression Scale (GDS) > 6, any recent suicide attempts or suicidal ideation. Subjects with a diagnosis of bipolar disorder may be included if they have been clinically stable for a minimum of 3 years prior to the Screening visit. Clinical stability to be determined by the Principal Investigator.
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 |
|---|---|---|
| SenicapocAlso: TRAM-3410 mg oral tablet | Drug | 10 mg daily Senicapoc |
| Placebo TabletPlacebo Oral Tablet | Other | Placebo Group |
Primary outcome
Change from Baseline in the Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog 13) score
Time frame: Baseline, Week 26, Week 52
ADAS-Cog 13 is a scale used to measure cognitive dysfunction in a number of neural domains. Total scores range from 0-70, with higher scores indicating greater cognitive impairment and a worse outcome.
Change from Baseline to Week 52 in levels of Cerebrospinal fluid (CSF) biomarkers: IL-1β, IL-6, TNF-α, MCP-1, and IL-10
Time frame: Baseline, Week 52
A lumbar puncture will be done and CSF collected at baseline prior to initiating study treatment and at Week 52 at the end of study treatment
Change from Baseline to Week 52 in levels of serum biomarkers: IL-6, TNF-α, MCP-1, and IL-10 and high sensitivity C-Reactive protein
Time frame: Baseline, Week 52
Blood draws will be done and serum processed at baseline prior to initiating study treatment and at Week 52 at the end of study treatment
16 secondary outcomes
Change from Screening in the Clinical Dementia Rating (CDR) sum of boxes score
Time frame: Screening, Week 26, Week 52
Change from Baseline in the Everyday Cognition (ECog) score
Time frame: Baseline, Week 26, Week 52
Change from Screening in Montreal Cognitive Assessment (MoCA) score
Time frame: Screening, Week 26, Week 52
Change from Baseline to Week 52 in Spanish English Neuropsychological Assessment Scales (SENAS) memory score
Time frame: Baseline, Week 52
Change from Baseline to Week 52 in Spanish English Neuropsychological Assessment Scales (SENAS) executive composite score
Time frame: Baseline, Week 52
Change from Baseline in Bushcke Cued Selective Reminding Task (CSRT) score
Time frame: Baseline, Week 26, Week 52
Change from Baseline in Trails B score
Time frame: Baseline, Week 26, Week 52
Change from Baseline in Verbal fluency (semantic) score
Time frame: Baseline, Week 26, Week 52
Change from Baseline in Verbal fluency (letter) score
Time frame: Baseline, Week 26, Week 52
Change from Baseline to Week 52 in Brain MRI measures of total grey matter.
Time frame: Baseline, Week 52
Change from Baseline to Week 52 in Brain MRI measures of total brain volume.
Time frame: Baseline, Week 52
Change from Baseline to Week 52 in Brain MRI measures of white matter hyperintensities.
Time frame: Baseline, Week 52
Change from Baseline to Week 52 in total grey matter florbetaben binding on amyloid Positron Emission Tomography (PET)
Time frame: Baseline, Week 52
Change from Baseline in Cognitive Event Related Potential (ERP) measures of P600 word repetition.
Time frame: Baseline, Week 26, Week 52
Change from Baseline in Cognitive Event Related Potential (ERP) measures of alpha suppression effect.
Time frame: Baseline, Week 26, Week 52
Change from Baseline in Cognitive Event Related Potential (ERP) measures of anti-coupling between early theta and late alpha/beta activity.
Time frame: Baseline, Week 26, Week 52
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 17 Aug 2026.
- Learn more or sign up for the study here!Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Investigator may share individual participant data collected, after de-identification, that supports the results reported in published articles (test, tables, figures, appendices)
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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.
John Olichney, MD principal investigator
University of California, Davis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Senicapoc in people with Mild Cognitive Impairment and Alzheimer Disease, run by University of California, Davis at 2 sites in United States.
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 24 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 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 Rita Venua ((916) 734-1708, rmvenua@ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog 13) score (time frame: Baseline, Week 26, Week 52). The study lists 3 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 17 Aug 2026.