Is NCT03507257 recruiting in San Francisco, CA?

Yes, NCT03507257 is currently recruiting participants at its San Francisco, CA location. This early onset alzheimer disease clinical trial is actively enrolling qualified participants.

Is participation in this San Francisco 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.

Early Onset Alzheimer Disease Clinical Trial in San Francisco, CA

Q: How do I join the early onset alzheimer disease clinical trial in San Francisco?

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

About This Early Onset Alzheimer Disease Study in San Francisco

The Longitudinal Early-onset Alzheimer's Disease Study (LEADS) is a non-randomized, natural history, non-treatment study designed to look at disease progression in individuals with early onset cognitive impairment. Clinical, cognitive, imaging, biomarker, and genetic characteristics will be assessed across three cohorts: (1) early onset Alzheimer's Disease (EOAD) participants, (2) early onset non-Alzheimer's Disease (EOnonAD) participants, and (3) cognitively normal (CN) control participants.

Sponsor: Indiana University

Who Can Participate

Inclusion Criteria

for Cognitively Impaired (EOAD and EOnonAD) Cohorts Only:

Meets NIA-AA criteria for MCI due to AD or probable AD dementia

Have a global CDR score ≤ 1.0

Have capacity to provide informed consent (IC) or has a legal authorized representative or guardian who provides IC

Age between 40-64 years (inclusive) at the time of consent

Must have a study partner (informant) who spends a minimum average of 10 hours per week with the participant (e.g., family member, significant other, friend, caregiver) who is generally aware of the participants' daily activities and can provide information about the participant's cognitive and functional performance. If the participant does not have a study partner who spends at least 10 face-to-face hours per week, other arrangements for identifying a viable study partner will be granted on a case-by-case basis by the Site PI

Willing and able to complete longitudinal study procedures aside from LP which is an optional procedure

Not pregnant or lactating. Women must be two years post-menopausal, be surgically sterile, or have a negative pregnancy test prior to each PET scan

Fluent in English or Spanish if enrolled in the U.S.

Fluent in English, Spanish, Dutch or Swedish for sites outside the U.S., according to site's spoken language(s). Inclusion Criteria for Cognitively Normal (CN) Cohort Only:

Meets criteria for cognitively normal, based on an absence of significant impairment in cognitive functions or activities of daily living

Have a global CDR score = 0

Have capacity to provide informed consent

Have a Mini-Mental State Exam score between 26-30 (inclusive). Exceptions may be made for participant with less than 8 years of education at the discretion of the Site PI

Age between 40-64 years (inclusive) at the time of consent

Must have a study partner (informant) who spends a minimum average of 10 hours per week with the participant (e.g., family member, significant other, friend, caregiver) who is generally aware of the participants' daily activities and can provide information about the participant's cognitive and functional performance. If the participant does not have a study partner who spends 10 face-to-face hours per week, other arrangements for identifying a viable study partner will be granted on a case-by-case basis by the Site PI

Willing and able to complete longitudinal study procedures aside from LP which is an optional procedure

Not pregnant or lactating. Women must be two years post-menopausal, be surgically sterile, or have a negative pregnancy test prior to each PET scan

Fluent in English or Spanish if enrolled in the U.S.

Fluent in English, Spanish, Dutch or Swedish for sites outside the U.S., according to site's spoken language(s).

Exclusion Criteria

for all (EOAD, EOnonAD and CN) cohorts:

Meets core clinical criteria for non-AD dementia

Two or more first degree relatives with a history of early-onset dementia suggestive of autosomal dominant transmission, unless known pathogenic mutations in APP, PSEN1, PSEN2, MAPT, GRN and C9ORF72 have been excluded

Known CLIA certified mutation in an ADAD gene (APP, PSEN1, PSEN2), or other autosomal dominant genes associated with other neurodegenerative disorders (MAPT, GRN, C9ORF72)

Contraindications to 3T MRI (e.g., claustrophobia, pacemaker, select aneurismal clip, artificial heart valve, select ear implants, select stents incompatible with 3T MRI, metal fragments or foreign objects in the eyes, skin or body, etc.)

Lifetime medical history of a brain disorder other than the disorder causing dementia except for headache (exceptions are allowed at the discretion of the Site PI - e.g., seizure disorder thought to be due to EOAD).

MRI scan with evidence of infection or focal lesions, cortical strokes, multiple lacunes (single lacune is allowable unless it meets criteria for strategic lacune affecting cognition)

Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol (at the discretion of the Site PI)

Research radiation exposure will be assessed by the study physician. If the candidate participant has had more than one nuclear medicine study in the prior 12 months for research-related purposes, study inclusion will require approval from the PET Core

Investigational agents are prohibited 30 days prior to entry

Previous enrollment in a therapeutic trial targeting amyloid or tau.

Participation in other clinical studies with neuropsychological measures, with the exception of participants who are co-enrolled in the NACC Uniform Data Set (UDS) protocol (Note: This criterion is intended to reduce repeat measures effects during neuropsychological testing. Exceptions are allowed at the discretion of the Site PI)

Lifetime history of schizophrenia spectrum disorders (DSM-5 criteria)

Current history (in previous 12 months) of DSM-5 diagnosis of mania, bipolar disorder with or without psychotic features

Current history (in previous 6 months) of moderate or severe substance abuse (nicotine or caffeine is allowed)

Suicidal behaviors in the past 12 months or active suicidal ideations

Residing in a 24-hour care skilled nursing facility (at the time of screening)

(For optional lumbar puncture procedure only): a. Clinical laboratory values must be within normal limits or, if abnormal, must be judged to be not clinically significant by the Site PI i. Platelet count \<100,000/ml ii. INR\>1.2 iii. Abnormal PT or PTT at screening b. Contraindications to the procedure, including but not limited to severe degenerative joint disease, deformity of the spine, history of a bleeding disorder c. Suspected elevated intracranial pressure, Arnold Chiari malformation or mass lesion d. Use of the anticoagulant medications such as but not limited to warfarin, rivaroxaban, dabigatran

Deemed ineligible by the Site PI for any other reason

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 San Francisco?

Yes, this clinical trial (NCT03507257) has an active research site in San Francisco, 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.

Early Onset Alzheimer Disease Treatment Options in San Francisco, CA

If you're searching for early onset alzheimer disease treatment options in San Francisco, CA, this clinical trial (NCT03507257) 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 San Francisco research site is actively enrolling participants for this clinical trial. You'll receive care from experienced early onset alzheimer 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 early onset alzheimer disease clinical trials near you to find additional studies recruiting in your area.

Early Onset Alzheimer Disease Clinical Trial in San Francisco, CA

Expert Care in San Francisco

IRB Approved

No-Cost Care

Apply for This San Francisco Location

Why Participate?

Simple Process