Memory Disorders Clinical Trials

For patient referrals, please reach out to:

Kaila Sevilla @ kailas44@stanford.edu and Pragya Tripathi @ pragyat@stanford.edu

Alzheimer's Dementia Trials

START Trial

Brief Summary: Synaptic Therapy Alzheimer’s Research Trial (START): Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer’s Disease over 18 Months.

This is a clinical research trial to understand whether an investigational drug, CT1812 safely slows down the memory loss caused by the Alzheimer’s disease.

CT1812 is an oral drug. If selected, particpants will be randomly assigned to one of three study groups :200 mg of CT1812 (active study drug) or 100 mg of CT1812 (active study drug) or Placebo(non-active drug for comparison).

The time commitment for this study is for about 22 months which includes screening period (upto 90 days), treatment period (approximately 72 weeks) and safety follow up (A telephone call follow-up Visit will occur 4 weeks +/- 2 days after completion of the final study visit at Week 72).

Who can participate:

•  Ages 50-85 years.
• Diagnosis of either Mild cognitive impairment or dementia due to Alzheimer’s Disease
•  Ability to swallow capsules.
• Plasma biomarkers result at screening consistent with Alzheimer’s Disease
• Amyloid PET scan of the brain or CSF biomarkers consistent with Alzheimer’s Disease
• Neuroimaging (MRI) obtained during screening consistent with the clinical diagnosis of Alzheimer’s Disease.
• Participants must have a study partner

If you are interested, please contact: Lanja Sinjary; lsinjary@stanford.edu; 650-507-7394

Sponsor: Cognition Therapeutics, Inc and National Institute on Aging (NIA)
Intervention: CT1812
Indication: Early Alzheimer’s Dementia
Age: ≥18 years
Clinicaltrials.gov identifier: https://classic.clinicaltrials.gov/ct2/show/NCT05531656
PI: Sharon Sha, MD
Learn more: https://start-study.org/

Bumetanide AD Trial:

Brief Summary: A Phase IIa, Randomized, Double-Blind, Active Placebo-Controlled, Parallel Group study to Evaluate the Safety and Tolerability of Bumetanide in patients with Alzheimer’s Disease

This is clinical research trial using Bumetanide to determine whether it can help slow the development of symptoms in people with early dementia due to Alzheimer’s Disease. Bumetanide is approved by the U.S. Food and Drug Administration (FDA) to treat swelling (edema) and high blood pressure but its use for slowing the symptoms in people with Alzheimer’s Disease symptoms is investigational.

This is an oral study drug. If selected, participants will be randomly assigned to 1 of 3 study groups to receive either:

• 0.25 mg bumetanide daily,
• 0.5 mg bumetanide daily, or
• a placebo (non-active drug for comparison)

Time commitment for this study is approximately 9 months which involves 7 study site visits and up to 4 follow-up phone calls.

The study will have 3 periods:

• Screening period (up to 12 weeks)
• Treatment period (6 months)
• Follow-up period (1 month)

Who can participate:

1. Male or female participants aged 50 to 85 years of age at the time of signing the informed consent form
2. Diagnosis of either mild cognitive impairment or mild dementia due to Alzheimer`s disease

- Gradual and progressive change in memory function for ≥ 6 months reported by subjects or study partner.

- Evidence of Alzheimer’s Diease pathological process, as confirmed on amyloid PET, plasma ptau-181, or cerebrospinal fluid amyloid-beta/phosphorylated tau index.

1. Ability to swallow bumetanide tablet.
2. Neuroimaging (MRI) obtained during screening or historic within a year of enrolment consistent with the clinical diagnosis of Alzheimer’s disease.
3. Resides at home or in the community (assisted living acceptable).
4. Participants must have a study partner.

If you are interested, please contact: Mina Kmiecik; mina.kmiecik@stanford.edu; 650-387-1559

Sponsor: Knight Initiative Brain Resilience Initiative Translational Grant, Stanford University
Intervention: Bumetanide
Indication: Mild Cognitive impairment or mild dementia due to Alzheimer’s disease
Clinicaltrials.gov identifier:  https://classic.clinicaltrials.gov/ct2/show/NCT06052163
PI: Kyan Younes, MD

LEADS (Longitudinal Early Onset Alzheimer's Disease Study)

Brief Summary: A natural history, non-treatment study designed to look at disease progression in individuals with early onset cognitive impairment (less than 65 years old).

This is a non-treatment study for adults diagnosed with early-onset Alzheimer’s disease (EOAD) and Early onset non-Alzheimer's Disease (EO-nonAD). Clinical/cognitive, imaging, biomarker, and genetic characteristics will be collected over 3 years.

Who can participate:

Cognitively impaired (EOAD and EOnonAD) Cohorts Only:

• Meets criteria for Mild Cognitive Impairment due to Alzheimer’s disease or dementia due to Alzheimer’s disease.
• Age between 40-64 years (inclusive) at the time of consent
• Must have a study partner who spends a minimum average of 10 hours per week with the participant.
• Must be fluent in English or Spanish

If you are interested, please contact: Stephanie Tran; trans@stanford.edu; 650-521-7287

Sponsor: Indiana University and NIA (LEADS)
Intervention: N/A - Observational
Indication: Early onset Alzheimer's Disease (EOAD), Early onset non-Alzheimer's Disease (EO-nonAD), and cognitively normal (CN)
Clinicaltrials.gov identifier: https://clinicaltrials.gov/study/NCT03507257
PI: Sharon Sha, MD
Learn more: https://www.alzheimers.gov/clinical-trials/longitudinal-early-onset-alzheimers-disease-study-leads

APEX Study

Brief Summary: AHEAD Plasma Extension study

This is an observational research study. The APEX study is designed to follow individuals who do not meet all the requirements to be in the AHEAD 3-45 Study. This study is to help researchers understand the changes in blood tests over time that may predict future risk of amyloid build-up, and to understand the decline in thinking and memory that may occur in older individuals who are at risk for developing Alzheimer’s Disease. The APEX study will compare people who did not have intermediate or amyloid levels in the brain (APEX participants) to individuals who did (AHEAD 3-45 Study). Researchers also hope to learn about the factors that may preserve memory and thinking in older individuals.

The APEX study will:

• Look at blood biomarkers to learn how they may be related to the progression of memory problems. A biomarker is a specific physical trait used to measure the progress of an Alzheimer’s dementia disease or condition.
• Follow memory and thinking tests over time.

Time commitment is four years where there will be one baseline visit and follow up visits every year for 4 years. At these visits, participant will have blood drawn and will take the same memory and thinking tests that they may have completed when they were taking screening tests for the AHEAD study.

Who can participate:

1. Previously consented Male or female participants aged 55 to 80 years of to participate in AHEAD A3-45 screening.
2. Has A3-45 screening plasma biomarker results required for determining eligibility to participate in the A3-45 trial.
3. If an amyloid PET scan was conducted in A3-45, the scan was determined to be below the 20 centiloid cut point required for eligibility into the treatment arms of the A3 or A45 trial.

If you are interested, please contact:
Mina Kmiecik; mina.kmiecik@stanford.edu; 650-387-1559
Sponsor: Brigham’s and Women’s Hospital
Intervention: N/A Observation
Indication: Healthy individuals with normal cognition at risk for Alzheimer’s disease
PI: Sharon Sha, MD
Learn more: https://www.actcinfo.org/alzheimers-plasma-extension-apex-study/

HD Project

Brief Summary: Neurodegenerative Disease Research Platform - Novel Remote Monitoring and Deep Phenotyping.

This is an observation study, and the goal of the study is to develop novel markers of disease onset and progression in neurodegenerative disease. This observational study will connect remote monitoring with biomarkers of neurodegenerative disease. Mobile app-based cognitive testing and video-based computer vision and machine learning algorithms will identify markers of neurodegenerative disease progression and link them to changes in plasma, skin biopsy, and cerebrospinal fluid with the goal of developing novel biomarkers and therapeutics.

This study consists of one in-person visit per year. The remaining assessments are remote (using video and mobile app assessments) once every three months for at least one year, and participants are invited to continue for as long as they wish for many years to come with the same schedule of events annually (i.e., one in-person visit and three remote evaluations per year)

Who can participate:

1. Individuals who has a neurovegetative disease diagnosis including but not limited to Huntington`s Disease, Alzheimer`s disease, Parkinson`s disease, Lewy Body Dementia, Frontotemporal Dementia, or Normal Pressure Hydrocephalous.

This group will be subdivided into two groups:

a. Clinical: Clinical features diagnostic of one of the neurodegenerative diseases.

b. Pre-clinical: Biomarker positive without clinical features diagnostic of neurodegenerative disease

2. Healthy aging controls.

3. Non-carrier family members of genetic mutations carriers.

If you are interested, please contact:
Minhtrang Chu; mtchu@stanford.edu; 650-250-3160

Sponsor: Schwab Charitable
Intervention: N/A observational trial
Indication: Neurovegetative disease diagnosis including but not limited to Huntington`s Disease, Alzheimer`s disease, Parkinson`s disease, Lewy Body Dementia, Frontotemporal Dementia, or Normal Pressure Hydrocephalous.
Age: ≥18 years
Clinicaltrials.gov identifier: N/A
PI: Kyan Younes, MD

ALZ-NET Registry study

Brief Summary: Patient registry for Alzheimer's Network for Treatment and Diagnostics (ALZ-NET)

This study is an observational study including people who are evaluated for or receive treatment with novel (or new) FDA-approved therapies for Alzheimer’s disease. ALZ-NET will follow and record information about people’s health, safety, brain scans, and long-term health outcomes during their regular memory care.  ALZ-NET aims to be a resource for evidence gathering, information sharing, and education across clinical and research communities to support and improve care of individuals living with Alzheimer’s disease.

Patients will be monitored if they are evaluated for treatment, throughout treatment duration, and following treatment completion for as long as they are willing. Patients may stop using any novel FDA-approved therapy for Alzheimer’s Disease, or any other commercially available non-investigational Alzheimer’s Disease therapy, during their ALZ-NET participation period. Patients who discontinue the FDA-approved therapy for Alzheimer’s Disease will continue to be followed for the duration of ALZ-NET with all clinical evaluations.

Who can participate:

1. Patient or patient’s legally authorized representative (LAR) or proxy (e.g., spouse or legal guardian) has the ability to understand the purpose and risks of ALZ-NET and provide signed and dated informed consent and authorization.
2. Patient is at least 18 years of age at the time of informed consent.
3. Patient has memory concerns and/or may have diagnosis of Alzheimer’s disease and has been identified by an approved site investigator (as defined by protocol) to be appropriate for treatment with novel FDA-approved AD therapies
4. Patient’s treating clinician has made the decision to treat the patient with novel FDA-approved therapy for AD independent of the purpose of ALZ-NET and has already or will be initiating treatment.      

If you are interested, please contact: Stephanie Tran; trans@stanford.edu; 650-521-7287

Sponsor: Alzheimer’s Association
Intervention: N/A observational trial. ALZ-NET will collect longitudinal clinical and safety data for enrolled patients treated with novel FDA approved AD therapies.
Indication: Alzheimer’s Dementia or other dementia
Clinicaltrials.gov identifier: N/A
PI:Kyan Younes, MD
Learn more: https://www.alz-net.org/

Sponsor: AriBio Co., Ltd.(AriBio Study-Polaris AD )
Intervention: AR1001
Indication: Early Alzheimer’s Disease
Age: ≥55 years
PI: Sharon Sha, MD
Learn more: https://www.earlyalzheimersdiseasestudy.com/
Brief Summary:  A Phase 3 Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of AR1001 in Participants with Early Alzheimer’s Disease.
Clinicaltrials.gov identifier: https://classic.clinicaltrials.gov/ct2/show/NCT05531526
Contact: Kaila Sevilla; kailas44@stanford.edu; 650- 454-5458

Sponsor: Biogen MA, Inc.(CELIA Study)
Intervention: BIIB080
Indication: MCI and Dementia
Age: 50-80 Years old
PI: Irina Skylar-Scott, MD
Learn more: https://www.biogentriallink.com/en-us/home/find-a-clinical-trial/clinical-trials-study-details.html?nctId=NCT05399888
Brief Summary: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of BIIB080 in Subjects with Mild Cognitive Impairment Due to Alzheimer’s Disease or Mild Alzheimer’s Disease Dementia
Clinicaltrials.gov identifier: https://classic.clinicaltrials.gov/ct2/show/NCT05399888
Contact: Olivia Lu; Olivialu@stanford.edu; 650-374-9286

Sponsor: Eisai and NIH (AHEAD 3-45 Study)
Intervention: BAN2401 (monoclonal antibody binding to amyloid)
Indication: Healthy individuals with normal cognition at risk for Alzheimer’s disease
Age: 55-80 years old
Brief Summary: A Placebo-Controlled, Double-Blind, Parallel-Treatment Arm, 216 Week Study to Evaluate Efficacy and Safety of Treatment With BAN2401 in Subjects With Preclinical Alzheimer’s Disease and Elevated Amyloid (A45 Trial) and in Subjects With Early Preclinical Alzheimer’s Disease and Intermediate Amyloid (A3 Trial)
Clinicaltrials.gov identifier: https://clinicaltrials.gov/study/NCT04468659
PI: Sharon Sha, MD
Contact: Mina Kmiecik; mina.kmiecik@stanford.edu; 650-387-1559

Sponsor: EIP Pharma,Inc.
Intervention: Neflamapimod
Indication: Dementia with Lewy Bodies
Brief Summary: EIP Pharma DLB Phase 2b: A Phase2b Clinical Study of the P38 Alpha Kinase Inhibitor Neflamapimod in Patients with Dementia with Lewy Bodies (DLB)
Age: ≥55 years
Clinicaltrials.gov identifier: https://classic.clinicaltrials.gov/ct2/show/NCT05869669
PI: Sharon Sha, MD
Contact: Kaila Sevilla; kailas44@stanford.edu; 650- 454-5458

Sponsor: Janssen Research & Development (Autonomy Study)
Intervention: JNJ-63733657 (monoclonal anti-tau antibody)
Indication: mild cognitive impairment and mild AD
Age: 55-80 years old
Brief Summary: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of JNJ-63733657, an Anti-tau Monoclonal Antibody, in Participants with Early Alzheimer’s Disease
Clinicaltrials.gov identifier: https://classic.clinicaltrials.gov/ct2/show/NCT04619420
PI: Sharon Sha, MD
Contact: Kaila Sevilla; kailas44@stanford.edu; 650- 454-5458

Sponsor: Eli Lilly (Trailblazer Study)
Intervention: Donanemab (monoclonal antibody binding to amyloid)
Indication: Early symptomatic AD
Age: 60-85 years
Brief Summary: Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer’s Disease (Trailblazer-Alz-2/I5T-MC-AACI)
Protocol NCT#: https://classic.clinicaltrials.gov/ct2/show/NCT04437511
PI: Sharon Sha, MD
Contact: Anthony Velasquez; anthgv@stanford.edu; 650-206-0963

Sponsor: Eisai (Clarity AD)
Intervention: BAN2401 (monoclonal antibody binding to amyloid)
Indication: MCI/Mild AD
Age: ≥50 and ≤90 years
Brief Summary: A Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study With an Open-Label Extension Phase to Confirm Safety and Efficacy of BAN2401 in Subjects With Early Alzheimer’s Disease (BAN2401-G000-301)
Clinicaltrials.gov identifier:  https://classic.clinicaltrials.gov/ct2/show/NCT01767311
PI: Sharon Sha, MD
Contact: Olivia Lu; olivialu@stanford.edu; 650-374-9286

Sponsor: NIA (Columbia University Primary)
Intervention: Metformin
Indication: MCI and Dementia
Age: 55-90 Years old
Brief Summary: Metformin in Alzheimer’s dementia Prevention (MAP)
Clinicaltrials.gov identifier: https://classic.clinicaltrials.gov/ct2/show/NCT04098666
PI: Irina Skylar-Scott, MD
Contact: Annie Zhou; anniez20@stanford.edu; 650-460-4151