Is NCT04804241 recruiting in Sacramento, CA?

Yes, NCT04804241 is currently recruiting participants at its Sacramento, CA location. This alzheimer's disease clinical trial is actively enrolling qualified participants.

How do I join the alzheimer's disease clinical trial in Sacramento?

To join this clinical trial in Sacramento, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Sacramento clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Alzheimer's Disease Clinical Trial in Sacramento, CA

About This Alzheimer's Disease Study in Sacramento

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-Co

Sponsor: University of California, Davis

Who Can Participate

Inclusion Criteria

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.

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.

Exclusion Criteria

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

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Sacramento?

Yes, this clinical trial (NCT04804241) has an active research site in Sacramento, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Alzheimer's Disease Treatment Options in Sacramento, CA

If you're searching for alzheimer's disease treatment options in Sacramento, CA, this clinical trial (NCT04804241) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Sacramento research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced alzheimer's disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all alzheimer's disease clinical trials near you to find additional studies recruiting in your area.

Alzheimer's Disease Clinical Trial in Sacramento, CA

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