Memory Disorders Clinical Trials

Featured Study

Cognition Trial (SHIMMER)

Dementia with Lewy bodies (DLB) is one of the most common causes of dementia. It is the second most common type of dementia diagnosed in older adults after Alzheimer’s disease (AD). In addition to worsening dementia and motor deficiency, patients with DLB endure a wide range of symptoms including cognitive fluctuations, recurrent visual hallucinations, and sleep disorders. Unfortunately, no treatments are available to cure or slow the progression of DLB.

This Phase 2 research study is designed to evaluate the safety and effectiveness of a study drug called CT1812, in adults between the ages of 50-85 who have been diagnosed with mild to moderate Dementia with Lewy Bodies disease (DLB).The purpose of this study is to learn about the safety of CT1812 and how well you or your loved one tolerate(s) a once-a-day dose of CT1812. The study will also test how well CT1812 will treat mild-to-moderate DLB. Certain proteins (called amyloid beta oligomers and α-synuclein oligomers) are believed to bind to brain cells in patients with DLB. CT1812 is intended to enter the brain and block these proteins from attaching to brain cells. It is hoped that by blocking these toxic proteins from binding to brain cells, patients with DLB will experience improved symptoms.

This research study is a randomized double-blind, controlled clinical study, which means that you/participant will randomly be assigned to one of three potential groups by chance, like the flip of a coin. You/participant will have a 66.6% chance of receiving the study drug versus a 33.4% chance of receiving a placebo.

Stanford Memory Disorders Clinical Trials

For patient referrals, please reach out to:

memoryresearch@stanford.edu

Active, Open for Enrollment

Active, Open for Enrollment

Lewy Bodies Dementia Trials

Cognition Trial (SHIMMER)
Sponsor
: Cognition Therapeutics Inc.
Intervention
: CT1812
Indication
: Mild or moderate Dementia with Lewy Bodies
Age: 50-85 years old
Brief
 Summary: A Randomized, Double-blind, Placebo-controlled, Phase 2, 6-month Study to Evaluate the Safety, Tolerability and Exploratory Efficacy of CT1812 in Subjects with Mild to Moderate Dementia with Lewy Bodies
Clinicaltrials.gov identifier: NCT05225415
PI
: Sharon Sha, MD
Contact
: Stephanie Tran

Who can participate

  1. Subjects must have a caregiver/ study partner
  2. Men or women 50-85 years of age (inclusive), meeting criteria for probable DLB .
  3. MMSE 18-27 inclusive.
  4. If receiving acetylcholinesterase inhibitors (AChEI), memantine or a combination of the two, must have been on a stable dose for at least 12 weeks before the screening visit.

 

EIP Pharma DLB Phase 2bTrial
Sponsor
: EIP Pharma,Inc.
Intervention: Neflamapimod
Indication: Dementia with Lewy Bodies
Age: ≥55 years
Brief Summary:  A Phase 2b Clinical Study of the P38 Alpha Kinase Inhibitor Neflamapimod in Patients with Dementia with Lewy Bodies (DLB)
Clinicaltrials.gov identifier: NCT04001517
PI
: Sharon Sha, MD
Contact:
Kaila Sevilla

Who can Participate:

  1. Men and women aged ≥55 years.
  2. Subject or subject’s legally authorized representative is willing and able to provide written informed consent.
  3. Probable DLB by consensus criteria (McKeith et al, 2017), including a positive DaTscan™. If the DaTscan is negative, but the subject has historical polysomnography (PSG)-verified REM sleep behavioral disorder (RBD), this will also qualify as probable DLB.
  4. CDR Global Score 0.5 or 1.0 during Screening.
  5. If the patient is currently receiving cholinesterase inhibitor therapy, the patient must have received such therapy for greater than 3 months and on a stable dose for at least 6 weeks at the time of randomization. Except for reducing the dose for tolerability reasons, the dose of cholinesterase inhibitor may not be modified during the study. If the patient is not currently receiving cholinesterase inhibitor therapy, but received such therapy previously, that therapy must have been discontinued at least 3 months prior to randomization. Memantine therapy is allowed, if it had been started at least 3 months prior to randomization and the patients is also receiving cholinesterase inhibitor therapy (memantine monotherapy, i.e., without concomitant cholinesterase inhibitor therapy, is excluded).
  6. Normal or corrected eyesight and auditory abilities, sufficient to perform all aspects of the cognitive and functional assessments.
  7. No history of learning difficulties that may interfere with their ability to complete the cognitive tests.
  8. Received vaccination for SARS-CoV-19, unless medical contraindications prevent being vaccinated. 9. Must have reliable informant or caregiver.

 

Alzheimer’s Dementia Trials

CELIA Trial
Sponsor
: Biogen MA, Inc.
Intervention: BIIB080
Indication:MCI and Dementia
Age: 50-80 Years old
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: NCT05399888
PI
: Irina Skylar-Scott, MD
Contact
: Olivia Lu

Who can participate:

  • Subjects must have a caregiver/ study partner.
  • Male and females aged 50 to 80 years, inclusive, at the time of informed consent.
  • Must meet all of the clinical criteria for MCI due to AD or mild AD dementia and must have the following at Screening Visit 1:
    •  RBANS Delayed Memory Index score of ≤ 85, indicative of objective evidence of memory impairment.
    • CDR global score of 0.5 for MCI due to AD or 0.5 or 1 for mild AD dementia.
    • MMSE score of 22 to 30 (inclusive).
    • CDR Memory Box score of ≥ 0.5.
  • Evidence of amyloid pathology as measured by PET or CSF sampling.
  • Must consent to APOE genotyping. The participant’s APOE status may be disclosed to him/her at the Investigator’s discretion.

 

ARI-Bio Trial (Polaris-AD)
Sponsor
: AriBio Co., Ltd.
Intervention: AR1001
Indication: Early Alzheimer’s Disease
Age: ≥55 years
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: NCT05531526
PI
: Sharon Sha, MD
Contact:
Kaila Sevilla

Who can Participate:

  1. Male or female participants aged 55 to 90 years of age inclusive at the time of signing the informed consent form
  2. Mild cognitive impairment or mild dementia consistent with AD defined by stages 3 to 4 according to the National Institute on Aging and Alzheimer’s Association (NIA-AA) (Jack et al., 2018) at Screening
  3. Participants with a history of subjective cognitive and memory decline with onset within 5 years before Screening, confirmed by study partner.
  4. Participants who have a MMSE score greater than or equal to 20
  5. Participants with a CDR global rating of 0.5 or 1
  6. Participants with a RBANS score based on the Delayed Memory Index (DMI) score less than or equal to 85
  7.  If an historic magnetic resonance imaging (MRI) is available, findings must exclude other causes of dementia
  8.  ositive biomarker for brain amyloid pathology as indicated by assessment of at least one of the following: a. Current or historic CSF with Lumipulseâ beta-amyloid ratio [1-42/1-40] ≤ 0.072 or Elecsysâ p-tau 181/Aβ[1-42] ≤ 0.028 b. Historic amyloid positron emission tomography (PET) assessment of imaging agent uptake into brain is acceptable to determine eligibility (PET confirmed by central read).
  9. Participants (or participant's legally authorized representative) and caregiver(s) who can sign an informed consent to participate in the study
  10. Participants who have one (or more) identified adult study partner(s) who, in the opinion of the Investigator, has sufficient contact with and knowledge about the participant as to be able to report knowledgably about the participant’s cognition, function, behavior, and safety, and compliance with the protocol. The informant/care partner must be available by phone to provide information to the Investigator and study staff about the participant as well as agree to attend in-person clinic visits that require partner input for scale completion. The informant/care partner must be literate and provide informed consent and should be available for the duration of the study. The same informant/care partner is required to be consistent across all study visits except under rare, unavoidable circumstances (e.g., unexpected informant health crisis) that are approved by the Investigator and Sponsor.

 

LEADS Trial
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)
Age: 40-64 years old
Brief
 Summary: A natural history, non-treatment study designed to look at disease progression in individuals with early onset cognitive impairment (less than 65 year old).
Clinicaltrials.gov identifier: NCT03507257
PI
: Sharon Sha, MD
Contact
: Stephanie Tran
Website: https://leads-study.medicine.iu.edu/about/leads-lectures-webinars/  

Who can participate

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
  • Fluent in English or Spanish

 

 

Coming soon in March 2024 Alzheimer’s Dementia Trials

MAP Trial
Sponsor
: NIA (Columbia University Primary)
Intervention: Metformin
Indication:MCI and Dementia
Age: 55-90 Years old
Brief
 Summary: Metformin in Alzheimer’s dementia Prevention
Clinicaltrials.gov identifier: NCT04098666
PI
: Irina Skylar-Scott, MD
Contact
: Olivia Lu

1. Diagnosis of aMCI:

  • Participants must have subjective memory concern reported by participant, study partner, or clinician.
  •  A mini-mental state exam ≥ 22 for participants with more than 8 years of education. For participants with less than 8 years of education, a MMSE ≥ 20 will be allowed.
  •  Clinical Dementia Rating = 0.5. The memory box score must be at least 0.5.
  • General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer’s disease cannot be made by the site physician at the time of the screening visit.
  • Abnormal memory function documented by scoring within the education adjusted ranges on the Logical Memory II subscale from the Wechsler Memory Scale-Revised.

 
2. For early MCI: 9-11 for 16 or more years of education

  • 5-9 for 8-15 years of education
  • 3-6 for 0-7 years of education


3. For late MCI

  •  ≤ 8 for 16 or more years of education
  • ≤ 4 for 8-15 years of education
  • ≤ 2 for 0-7 years of education


4. Age range: 55 years to 90 years.

5. Sex distribution: all eligible men and women will be included, and no one will be excluded because of gender.

6. Languages: fluent in English or Spanish. We have reliable, well-validated Spanish tests for all outcome measures.

7. Participants without a known history of diabetes. If diabetes is diagnosed during screening (hemoglobin A1c [HbA1c] of 6.5% or greater) participants will be excluded. The main justification for this exclusion is the potential for these participants to be placed on other diabetes medications that may confound our study.

8. General cognition and functional performance such that a diagnosis of dementia cannot be made at the time of screening based on DSM-V criteria.

9. Vision and hearing must be sufficient for compliance with testing procedures.

10. Must have a study partner to come to all appointments or be available by telephone at follow-up visits.


Study Partner Inclusion Criteria

  1. The study partner can provide an independent evaluation of functioning for a person enrolled in the MAP study as a participant.
  2. The study partner agrees to attend study visits with the MAP participant or be available by telephone.

 

ALZ-NET Trial
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
Age: ≥18 years
Brief Summary: Patient registry for Alzheimer's Network for Treatment and Diagnostics (ALZ-NET)
Clinicaltrials.gov identifier: N/A
PI
:Kyan Younes, MD
Contact:
Kaila Sevilla

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 to use protected health information (PHI) in accordance with national and local patient privacy regulations.
  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 (AD) and has been identified by an approved site investigator (as defined by protocol) to be appropriate for treatment with novel FDA-approved AD therapies in real world clinical practice.
  4. Patient meets appropriate label designations according to appropriate use recommendations for novel FDA-approved AD therapy/therapies.
  5. 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.

 

Bumetanide AD Trial
Sponsor
: Knight Initiative Brain Resilience Initiative Translational Grant, Stanford University
Intervention
: Bumetanide
Indication
: Mild Cognitive impairment or mild dementia due to Alzheimer’s
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
Clinicaltrials.gov identifier:  NCT06052163.
PI
: Kyan Younes,MD
Contact
: Mina Kmiecik

Who can participate:

1. Ages 50-85 years, inclusive.

2. Diagnosis of either mild cognitive impairment due to Alzheimer`s disease or mild dementia due to Alzheimer`s disease with evidence of the AD pathophysiological process according to National Institute on Aging and Alzheimer’s Association (NIA-AA) criteria. Global CDR score of 0.5 (for MCI due to AD) and 0.5 to 1 (for mild AD).

Operational Diagnostic Process Inclusion Criteria for AD Subjects:

  • Gradual and progressive change in memory function for ≥ 6 months reported by subjects or study partner.
  • Screening MMSE score 18-30 inclusive.
  • Evidence of AD pathological process, as confirmed on amyloid PET, plasma ptau-181, or cerebrospinal fluid amyloid-beta/phosphorylated tau index.
  •  Willingness and ability to complete all aspects of the study including assessments, neuropsychological testing, and MRI.
  • AD medication is planned to remain stable throughout.


3. Persons with female biological sex, must be of non-childbearing potential. Persons with male biological sex who are sexually active must agree to use acceptable contraceptives during the trial and for 3 months after their last dose unless their partner is using an acceptable means of birth control or is of non-childbearing potential.

4. Persons with male biological sex who are sexually active with a female of child-bearing potential must agree to use condoms during the trial and for 3 months after the last dose unless the female is using an acceptable means of birth control. Acceptable forms of birth control include abstinence, birth control pills, or any double combination of intrauterine device (IUD), male or female condoms, diaphragm, sponge, and cervical cap.

5. Ability to swallow bumetanide tablet.

6. Plasma amyloid or tau consistent with Alzheimer’s disease.

7. Neuroimaging (MRI) obtained during screening or historic within a year of enrolment consistent with the clinical diagnosis of Alzheimer’s disease.

8. Stable dose of permitted medications for 30 days prior to screening or 60 days prior to screening for medications that affect cognitive function.

9. Resides at home or in the community (assisted living acceptable).

10. In the opinion of the PI, has a study partner able and willing to provide accurate information about the participant, oversee the administration of study drug, and participate in study visits and informant-based assessments (usually requires at least 5 hours of contact per week).

11. As assessed by the PI, participant is likely to be able to comply with the protocol, including completion of all screening evaluations, and has adequate vision, hearing (hearing aid permitted), and literacy in English sufficient for compliance with required testing procedures.

 

 Cognitively Normal patient population trials

 

AHEAD 3-45 Trial
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:
 NCT04468659
PI
: Sharon Sha, MD
Contact: Jade Perry
Study Link: https://studypages.com/s/the-ahead-study-440395/

Who can participate

1. Male or female, age 55 to 80 years inclusive at the time of informed consent.

a. Those 55 to 64 must have 1 of the following additional risk factors:

i. First degree relative diagnosed with dementia onset before age 80, or

ii. Known to possess at least 1 apolipoprotein є4 variant (APOE4) allele, or

iii. Known before Screening to have elevated brain amyloid according to previous PET or CSF testing. Individuals with historical amyloid PET scans with Aβi (eg, from preclinical AD studies such as A4 or EARLY) are eligible to be screened, provided the subject did not participate in any clinical studies involving anti-amyloid therapies subsequent to the PET assessment.

2. Global CDR score of 0 at Screening

3. Mini Mental State Examination (MMSE) score ≥27 (with educational adjustments) at Screening

4. Wechsler Memory Scale-Revised Logical Memory subscale II (WMS-R LM II) score at Screening of ≥6

5. A45 Trial: Elevated brain amyloid pathology by amyloid PET: defined as approximately >40 centiloids on Screening scan.

A3 Trial: Intermediate levels of brain amyloid pathology by amyloid PET: defined as approximately 20 to 40 centiloids on screening scan.

 6. Has a study partner that is willing to participate as a source of information and has approximately weekly contact with the participant (contact can be in-person, via telephone or electronic communication).

 

Active, not recruiting

Sponsor: American College of Radiology (New IDEAS)
Intervention
: N/A - Observational
Indication
: MCI and dementia
Brief
 Summary: New IDEAS: Imaging Dementia—Evidence for Amyloid Scanning Study
A Study to Improve Precision in Amyloid PET Coverage and Patient Care
Clinicaltrials.gov identifier: NCT02420756
PI
: Sharon Sha, MD
Contact
: Anthony Velasquez

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: NCT04619420
PI
: Sharon Sha, MD
Contact:
Kaila Sevilla

Sponsor: Eli Lilly (Trailblazer Study)
Intervention
: Donanemab (monoclonal antibody binding to amyloid)
Indication: early symptomatic AD.
Protocol NCT#: 
NCT04437511
PI: 
Sharon Sha, MD
Contact:Jade Perry

Sponsor: Eisai (Clarity AD)
Intervention
: BAN2401 (monoclonal antibody binding to amyloid)
Indication
: MCI/Mild AD
Clinicaltrials.gov identifier:  
NCT03887455
PI
: Sharon Sha, MD
Contact: Olivia Lu