Memory Disorders Clinical Trials

For patient’s referral please reach out to:
Kaila Sevilla @ kailas44@stanfod.edu
Pragya Tripathi @pragyat@stanford.edu

Active, Open for Enrollment

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; Olivialu@stanford.edu;  650-374-9286

Who can participate:

• Ability of the participant and/or his/her legally authorized representative (e.g., parent, spouse, or legal guardian), as appropriate and applicable, to understand the purpose and risks of the study, to provide informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations.
• Male and females aged 50 to 80 years, inclusive, at the time of informed consent.
• All women of childbearing potential and all men must practice highly effective contraception during the study and for 52 weeks after their last dose of study treatment. In addition, participants should not donate sperm or eggs during the study and for at least 52 weeks after their last dose of study treatment.
• 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.
•  Confirmation of evidence of cerebral Aβ accumulation, as determined by a centrally read amyloid PET scan of the brain or by CSF testing. Any of the following amyloid PET tracers may be used to confirm cerebral Aβ pathology on PET: 18Fflorbetapir, 18Fflutemetamol, or 18Fflorbetaben. A previously obtained amyloid PET scan within approximately 24 months of Screening Visit 1 is permissible for participants and must be submitted to the central imaging vendor to confirm that study inclusion criteria are met. A previously obtained CSF confirmation of amyloid positivity is not sufficient to meet this criterion.

Note: If a participant enters the study based on a cerebral Aβ positivity as determined by a previous amyloid PET scan, the PET result takes precedence for purposes of determining eligibility.

• Must consent to APOE genotyping. The participant’s APOE status may be disclosed to him/her at the Investigator’s discretion.
• Must have 1 care partner who, in the Investigator’s judgment, has frequent and sufficient contact with the participant (at least 10 hours/week) as to be able to provide accurate information about the participant’s cognitive and functional abilities. The care partner must agree to accompany the participant to clinic visits and/or be available by telephone at designated times to provide information to the Investigator and study staff about the participant (and to attend in-person clinic visits that require care partner input for scale completion) and must agree to monitor the participant’s administration of any prescribed medications. A care partner should be available for the duration of the study, and the participation of the same care partner for the duration of the study is encouraged. The care partner must be literate and provide informed consent.
• Apart from a clinical diagnosis of MCI due to AD or mild AD dementia, the participant must be in good health as determined by the Investigator, based on medical history and screening assessments.
   

AHEAD 3-45 Trial
Sponsor: Eisai and NIH (AHEAD 3-45 Study)
Intervention: BAN2401 (monoclonal antibody binding to amyloid)
Indication: Pre-clinical AD
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; jadep@stanford.edu; 650-521-7287
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, given the relatively low rates of amyloid positivity <65 years:

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). The study partner must have sufficient contact such that the investigator feels the study partner can provide meaningful information about the subject’s daily function.

7. Provide written informed consent

8. Willing and able to comply with all aspects of the protocol

New IDEAS Trial
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:Warsameh Bulhan ;whbulhan@stanford.edu;650-460-4151

Who can participate:

• Medicare beneficiary with Medicare as primary insurance.
• Meets clinical criteria for Mild Cognitive Impairment (MCI) or Dementia as defined by the 2018 National Institute on Aging – Alzheimer’s Association Research Framework
• Brain MRI and/or CT within 24 months prior to enrollment.
• Clinical laboratory assessment (complete blood count [CBC], comprehensive metabolic panel [CMP], thyroid stimulating hormone [TSH], vitamin B12) within the 12 months prior to enrollment.
• Able to tolerate amyloid PET required by protocol, to be performed at a participating PET facility.
• English or Spanish speaking (for the purposes of informed consent);
• Willing and able to provide consent. Consent may be by proxy.
• Neuropsychiatric syndrome can be classified into “clinically typical” or “clinically atypical” categories.

Cognition (Shimmer) Trial
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; trans@stanford.edu; 650-521-7287

Who can participate

1) Subjects or their Legally Authorized Representative (LAR) (or designee as applicable by local law) must provide written informed consent to the study procedures prior to any study procedures.

2) Subjects must have a caregiver/ study partner who in the opinion of the site principal investigator, has contact with the study subject for a sufficient number of hours per week to provide informative responses on the protocol assessments, oversee the administration of study drug, and is willing and able to participate in all clinic visits and some study assessments. The caregiver/ study partner must provide written informed consent to participate in the study.

3) Men or women 50-85 years of age (inclusive), meeting criteria for probable DLB .

4) Men willing to comply with acceptable form of contraception or women of non-childbearing potential as defined below:

 i) Non-childbearing potential for women is defined as postmenopausal (last natural menses greater than 24 months) or undergone a documented bilateral tubal ligation or hysterectomy. If last natural menses less than 24 months, a serum FSH value confirming post-menopausal status can be employed.

 ii) Male subjects who are sexually active with a woman of childbearing potential must agree to use condoms during the trial and for 3 months after last dose unless the woman 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 condom, diaphragm, sponge, and cervical cap.

5) MRI (or CT scan due to contraindication of MRI, if approved by medical monitor) obtained during screening consistent with the clinical diagnosis of DLB and without findings of significant exclusionary abnormalities. An historical MRI (or CT scan), up to 1 year prior to screening, may be used as long as there is no history of intervening neurologic disease or clinical events (such as a stroke, head trauma etc.) and the subject is without clinical symptoms or signs suggestive of such intervening events.

 6) MMSE 18-27 inclusive.

7) 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, with no plans for dose adjustment during the study. Treatment-naive subjects can be entered into the study, but there should be no plans to initiate treatment with AChEIs or memantine from Screening to the end of the study.

8) Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening.

9) Formal education of eight or more years.

10) Subjects living at home or in an assisted living facility.

11) Ability to swallow capsules.

12) Must consent to apolipoprotein E (ApoE) genotyping.

13) Subjects shall be generally healthy with mobility (ambulatory or ambulatory-aided, i.e., walker or cane), vision and hearing (hearing aid permissible) sufficient for compliance with testing procedures.

14) Must be able to complete all screening evaluations.

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; trans@stanford.edu; 650-521-7287

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 (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

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

Coming soon in December 2023

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; kailas44@stanford.edu; 650- 454-5458

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.

ENVISION Trial
Sponsor: Biogen MA. Inc.
Intervention: Aducanumab(221AD305)
Indication: MCI due to Alzheimer’s disease or mild Alzheimer’s disease dementia.
Age: 60-85 years old
Brief Summary: A Phase 3b/4 Randomized, Double-Blind, Placebo-Controlled, Parallel- Group Study to Verify the Clinical Benefit of Aducanumab (BIIB037) in Participants with Alzheimer's Disease
Clinicaltrials.gov identifier: NCT05310071
PI: Sharon Sha, MD
Contact: Olivia Lu; Olivialu@stanford.edu; 650-374-9286
Jade Perry; jadep@stanford.edu; 650-521-7287

Who can participate:

1. The participant and/or his/her legally authorized representative (e.g., parent, spouse, or legal guardian, where local regulations and institutional practices permit) must be able, as appropriate and applicable, to understand the purpose and risks of the study, to provide signed and dated informed consent, and to authorize the use of confidential health information in accordance with national and local privacy and ethics regulations.
2. The participant must be 60 to 85 years old, inclusive, at the time of informed consent.
3. All women of childbearing potential must practice effective contraception during the study and for 5 times the half-life or 24 weeks (whichever is longer) after their last dose of study treatment.
4. The participant must have a minimum of 9 years of education or vocational training or the equivalent education/vocational training until the age of 15 or, per Investigator judgment, work experience that indicates a lack of mental deficits other than early-stage dementia.
5. The participant must have confirmed amyloid beta pathology by CSF (historical CSF test results not allowed) or amyloid PET. If providing only a screening amyloid PET scan for amyloid positivity, a historical, amyloid PET scan obtained within 18 months of Screening Visit 2 is permissible. Sponsor-approved tracers must be used and scans must be submitted to the central imaging vendor to confirm that study inclusion criteria are met. In the case of discordant results between CSF and PET, PET results will be used to assess eligibility.
6. The participant must have a history of subjective memory decline with gradual onset and slow progression over the last 6 months before Screening, confirmed by study partner.
7. The participant must meet all of the following clinical criteria for MCI due to Alzheimer’s disease or mild Alzheimer’s disease:
   1. Have an MMSE score between 22 and 30 inclusive
   2. Have a CDR memory score ≥ 0.5
   3. Have a CDR-GS of 0.5 or 1.0
   4. Have an RBANS score of 85 or lower indicative of objective cognitive impairment (based upon the DMI score)
8. The participant must be in good health, apart from a clinical diagnosis of early Alzheimer’s disease, as determined by the Investigator based on medical history and screening assessments.
9. The participant must consent to ApoE genotyping.
10. The participant must have 1 informant/care partner who, in the Investigator’s opinion, has frequent and sufficient contact with the participant (at least 10 hours/week in person or by phone) as to be able to provide accurate information about the participant’s cognitive and functional abilities over time. The informant/care partner ideally has known the participant prior to their cognitive decline to have a reference point for change across time. 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.

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; kailas44@stanford.edu; 650- 454-5458

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.