Active, recruiting:
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
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: Anthony Velasquez; anthgv@stanford.edu;650-206-0963
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:Jade Perry; jadep@stanford.edu; 650-521-7287
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 Trial
Sponsor: Cognition Therapeutics Inc.
Intervention: CT1812
Indication: Mild or moderate AD 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.
Coming soon in July once FDA approves Leqembi
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.
