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CompletedNCT04994483RETHINK-ALZUpdated May 25, 2025Results posted

Simufilam 100 mg for Mild-to-Moderate Alzheimer's Disease

A Phase 3 interventional study of Simufilam and Placebo in Alzheimer Disease, sponsored by Cassava Sciences, Inc.. Completed at 88 sites in 3 countries. Open to participants aged 50 Years to 87 Years. Per ClinicalTrials.gov, last updated 2025-05-25.

Sponsored by Cassava Sciences, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
804
Allocation
Randomized
Ages
50 Years to 87 Years
Sex
All
01

Study summary

A 52-week safety and efficacy study of simufilam (PTI-125) given twice daily to participants with mild-to-moderate Alzheimer's disease (AD) for 52 weeks. Approximately 750 participants will be randomized (1:1) to receive either placebo or 100 mg tablets of simufilam, twice daily, for 52 weeks. Clinic visits will occur 4 weeks after the baseline visit, and then every 12 weeks until the end of the study. The safety of simufilam, and its efficacy in enhancing cognition and slowing cognitive and functional decline will be evaluated.

Read the detailed description

The primary objective of this study is to investigate the safety and efficacy of simufilam (PTI-125) in enhancing cognition and slowing cognitive and functional decline following 52-week, repeat-dose oral administration in participants with mild-to-moderate AD. Secondary objectives include the assessment of simufilam's effect on neuropsychiatric symptoms and caregiver burden. A third objective is to investigate the effect of simufilam treatment on plasma biomarkers. A limited number of research sites will be invited to participate in the pharmacokinetic (PK) and plasma biomarker sub-study. Collection of PK samples will enable an exposure-response analysis. Approximately 100 subjects will participate (50 per group). Plasma samples will be collected during the Screening Visit and again at Weeks 28 and 52. Change from Baseline for plasma biomarkers represent additional secondary endpoints.

Safety will be evaluated by adverse event monitoring, vital signs, clinical labs, and the Columbia Suicide Severity Rating Scale at every visit. Subjects will undergo magnetic resonance imaging (MRI) during screening to ensure entry criteria are met (unless recent MRI confirms entry criteria). Resting electrocardiograms will be conducted at Baseline (Study Day 1) and Weeks 4, 28, and 52. A complete physical and neurological examination will be performed at screening, and brief examinations will be performed at all other visits. Weight will be measured during the Screening Period, at Baseline (Study Day 1), and at all other visits.

An independent Data Safety Monitoring Board (DSMB) will meet periodically to review subject safety assessments and determine if dosing may continue. A charter will be developed with specific guidance for the DSMB.

02

Conditions studied

  • Alzheimer Disease

Browse trials for

03

In context

Alzheimer Disease

3,675 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.

This study's enrollment of 804 is above the median of 70 across 2,805 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Cassava Sciences, Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 87 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  1. Meets National Institute on Aging and Alzheimer's Association Research Framework criteria for individuals in clinical Stage 4 or 5 of the Alzheimer's continuum.
  2. Evidence for AD pathophysiology, confirmed either prior to or during screening.
  3. MMSE score ≥ 16 and ≤ 27 at screening.
  4. Clinical Dementia Rating - Global Score must be 0.5, 1 or 2.
  5. If receiving background AD medications, the dosing regimen must be stable for at least 12 weeks prior to randomization. Chronic medications for conditions other than AD (such as depression) must be prescribed at a stable dose for at least 4 weeks prior to screening.
  6. The subject has not been a cigarette smoker or chewed tobacco for at least 3 years.
  7. Availability of a study partner.
  8. Individuals who have participated in a clinical study with an investigational drug targeting the underlying AD process may be permitted to participate in this study.
  9. Completed a COVID-19 vaccine primary series ("fully vaccinated") at least 2 weeks prior to randomization or had an unambiguous COVID-19 infection diagnosed more than 3 months before the start of the Screening Period.

Key Exclusion Criteria:

  1. A neurologic condition other than AD that significantly contributes to the subject's dementia.
  2. Any current primary psychiatric diagnosis other than AD if it is likely to confound cognitive assessment or ability to comply with study procedures.
  3. Geriatric Depression Scale (15-item) score > 8. (Note - a subject with a score > 8 may continue in screening if, in the judgment of the Investigator, the elevated score is not attributed to a major depressive episode).
  4. Suicidal ideation during the past 3 months or suicidal behavior during the past 12 months.
  5. Alcohol or substance use disorder within 2 years of screening.
  6. MRI presence of cerebral vascular or other significant pathology.
  7. History of transient ischemic attack or stroke within 12 months of screening
  8. Seizure within 12 months of screening.
  9. Severe head trauma or head trauma considered likely to be contributing to the subject's cognitive impairment.
  10. Sleep apnea that is considered likely to be contributing to the subject's cognitive impairment.
  11. Insufficiently controlled diabetes mellitus or hypertension.
  12. Body mass index \< 18.5 or > 37.5.
  13. History or diagnosis of clinically significant cardiac disease
  14. Currently or previously prescribed/administered aducanumab, lecanemab, or any anti-amyloid monoclonal antibody, more than 2 doses.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
804 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 52 weeks

    Drug: Placebo

  • Experimental
    Simufilam 100 mg

    Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 52 weeks

    Drug: Simufilam

Interventions

  • DrugSimufilam

    Simufilam is a novel drug candidate designed to treat and slow the progression of AD. Simufilam binds with femtomolar affinity to an altered conformation of filamin A that is present in the brain of patients with AD and critical to the toxicity of Aβ42. In this study, simufilam will be given b.i.d. for 52 weeks at a dose of 100 mg.

    Also known as: PTI-125

  • DrugPlacebo

    Matching placebo given b.i.d. for 52 weeks.

06

What researchers measure

Primary outcomes

  1. Change From Baseline in the 12-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12)

    The change from baseline to Week 52 in the ADAS-Cog12, a psychometrician-administered battery comprised of several cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Scores range from 0 (best) to 80 (worst).

    Time frame: Baseline (Study Day 1) to Week 52

  2. Change From Baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)

    The change from baseline to Week 52 in the ADCS-ADL, a 23-item study partner questionnaire that covers both basic activities of daily living (ADL) and more complex ADL or instrumental ADL. Scores range from 0 to 78, with a lower score indicating greater severity of functional loss.

    Time frame: Baseline (Study Day 1) to Week 52

Secondary outcomes

  1. Change From Baseline in the Integrated Alzheimer's Disease Rating Scale (iADRS)

    The change from baseline to Week 52 in the iADRS, where scores range from 0 to 146 with lower scores indicating worse performance.

    Time frame: Baseline (Study Day 1) to Week 52

  2. Change From Baseline in the Neuropsychiatric Inventory (NPI)

    The change from baseline to Week 52 in the NPI, a 12-item study partner interview, which records the frequency and severity of common neuropsychiatric symptoms in dementia, as well as the level of study partner distress due to each of the neuropsychiatric problems. Scores range from 0 to 144, with higher scores indicating more frequent and severe symptoms, and greater levels of partner distress.

    Time frame: Baseline (Study Day 1) to Week 52

  3. Change From Baseline in the Mini-Mental State Exam (MMSE)

    The change from baseline to Week 52 in the MMSE, a set of standardized questions covering several target areas: orientation, registration, attention and calculation, short-term verbal recall, naming, repetition, 3-step command, reading, writing, and visuospatial cognitive assessment. Scores range from 0 to 30, lower scores indicate more severe impairment.

    Time frame: Baseline (Study Day 1) to Week 52

  4. Change From Baseline in the Clinical Dementia Rating Sum of Boxes (CDR-SB)

    The change from baseline to Week 52 in the CDR-SB, which characterizes 6 domains of cognitive and functional performance applicable to AD and related dementias: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Scores for each domain have a minimum of 0 and a maximum of 3, and the 6 domain scores are summed to give the CDR-SB, which has a minimum score of 0 and a maximum score of 18. Higher scores indicate more severe impairment.

    Time frame: Baseline (Study Day 1) to Week 52

  5. Change From Baseline in the Zarit Burden Interview (ZBI)

    The change from baseline to Week 52 in the ZBI, a 22-item study partner questionnaire designed to assess the stress or burden experienced by caregivers of people with dementia. Scores range from 0 to 88, with a higher score indicating greater stress or burden.

    Time frame: Baseline (Study Day 1) to Week 52

Other outcomes

  1. Changes From Baseline in Plasma Biomarkers

    Change from baseline in the following plasma biomarkers of AD pathology, neurodegeneration, and neuroinflammation: phospho-tau217 (P-tau217), glial fibrillary acidic protein (GFAP), neurofilament light chain (NfL), and total tau.

    Time frame: Baseline (Study Day 1) to Week 52

  2. Changes From Baseline in the Plasma SavaDx Biomarker

    Change from baseline in SavaDx, a novel plasma biomarker

    Time frame: Baseline (Study Day 1) to Week 52

07

Results

Posted May 25, 2025

Participant flow

Participant flow — Overall Study
MilestoneSimufilam 100 mgPlacebo
Started403401
Completed310325
Not completed9376
Withdrew: Adverse event2617
Withdrew: Lost to follow-up610
Withdrew: Noncompliance with study drug85
Withdrew: Physician decision50
Withdrew: Withdrawal by subject4138
Withdrew: Sponsor requests subject to be withdrawn21
Withdrew: Met stopping criteria10
Withdrew: Randomized in error, not treated43
Withdrew: Lack of a reliable study partner01
Withdrew: Met mri exclusion criteria01

Outcome measures

PrimaryChange From Baseline in the 12-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12)

The change from baseline to Week 52 in the ADAS-Cog12, a psychometrician-administered battery comprised of several cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Scores range from 0 (best) to 80 (worst).

Time frame:
Baseline (Study Day 1) to Week 52
Reported as:
Least squares mean · score on a scale
Change From Baseline in the 12-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12)
score on a scaleSimufilam 100 mgPlacebo
Change From Baseline in the 12-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12)2.79 ± 0.3633.19 ± 0.359
Statistical analysis
  • Simufilam 100 mg vs Placebo · Mixed Models Analysis · p = 0.4308 · Mean difference (final values): -0.39 · 95% CI -1.37 to 0.59
PrimaryChange From Baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)

The change from baseline to Week 52 in the ADCS-ADL, a 23-item study partner questionnaire that covers both basic activities of daily living (ADL) and more complex ADL or instrumental ADL. Scores range from 0 to 78, with a lower score indicating greater severity of functional loss.

Time frame:
Baseline (Study Day 1) to Week 52
Reported as:
Least squares mean · score on a scale
Change From Baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
score on a scaleSimufilam 100 mgPlacebo
Change From Baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)-3.26 ± 0.442-3.76 ± 0.438
Statistical analysis
  • Simufilam 100 mg vs Placebo · Mixed Models Analysis · p = 0.4034 · Mean difference (final values): 0.51 · 95% CI -0.68 to 1.70
SecondaryChange From Baseline in the Integrated Alzheimer's Disease Rating Scale (iADRS)

The change from baseline to Week 52 in the iADRS, where scores range from 0 to 146 with lower scores indicating worse performance.

Time frame:
Baseline (Study Day 1) to Week 52
Reported as:
Least squares mean · score on a scale
Change From Baseline in the Integrated Alzheimer's Disease Rating Scale (iADRS)
score on a scaleSimufilam 100 mgPlacebo
Change From Baseline in the Integrated Alzheimer's Disease Rating Scale (iADRS)-5.53 ± 0.605-6.49 ± 0.598
SecondaryChange From Baseline in the Neuropsychiatric Inventory (NPI)

The change from baseline to Week 52 in the NPI, a 12-item study partner interview, which records the frequency and severity of common neuropsychiatric symptoms in dementia, as well as the level of study partner distress due to each of the neuropsychiatric problems. Scores range from 0 to 144, with higher scores indicating more frequent and severe symptoms, and greater levels of partner distress.

Time frame:
Baseline (Study Day 1) to Week 52
Reported as:
Least squares mean · score on a scale
Change From Baseline in the Neuropsychiatric Inventory (NPI)
score on a scaleSimufilam 100 mgPlacebo
Change From Baseline in the Neuropsychiatric Inventory (NPI)0.54 ± 0.5880.90 ± 0.579
SecondaryChange From Baseline in the Mini-Mental State Exam (MMSE)

The change from baseline to Week 52 in the MMSE, a set of standardized questions covering several target areas: orientation, registration, attention and calculation, short-term verbal recall, naming, repetition, 3-step command, reading, writing, and visuospatial cognitive assessment. Scores range from 0 to 30, lower scores indicate more severe impairment.

Time frame:
Baseline (Study Day 1) to Week 52
Reported as:
Least squares mean · score on a scale
Change From Baseline in the Mini-Mental State Exam (MMSE)
score on a scaleSimufilam 100 mgPlacebo
Change From Baseline in the Mini-Mental State Exam (MMSE)-1.95 ± 0.223-2.14 ± 0.221
SecondaryChange From Baseline in the Clinical Dementia Rating Sum of Boxes (CDR-SB)

The change from baseline to Week 52 in the CDR-SB, which characterizes 6 domains of cognitive and functional performance applicable to AD and related dementias: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Scores for each domain have a minimum of 0 and a maximum of 3, and the 6 domain scores are summed to give the CDR-SB, which has a minimum score of 0 and a maximum score of 18. Higher scores indicate more severe impairment.

Time frame:
Baseline (Study Day 1) to Week 52
Reported as:
Least squares mean · score on a scale
Change From Baseline in the Clinical Dementia Rating Sum of Boxes (CDR-SB)
score on a scaleSimufilam 100 mgPlacebo
Change From Baseline in the Clinical Dementia Rating Sum of Boxes (CDR-SB)1.04 ± 0.1380.85 ± 0.136
SecondaryChange From Baseline in the Zarit Burden Interview (ZBI)

The change from baseline to Week 52 in the ZBI, a 22-item study partner questionnaire designed to assess the stress or burden experienced by caregivers of people with dementia. Scores range from 0 to 88, with a higher score indicating greater stress or burden.

Time frame:
Baseline (Study Day 1) to Week 52
Reported as:
Least squares mean · score on a scale
Change From Baseline in the Zarit Burden Interview (ZBI)
score on a scaleSimufilam 100 mgPlacebo
Change From Baseline in the Zarit Burden Interview (ZBI)2.52 ± 0.5562.30 ± 0.551
Other pre-specifiedChanges From Baseline in Plasma Biomarkers

Change from baseline in the following plasma biomarkers of AD pathology, neurodegeneration, and neuroinflammation: phospho-tau217 (P-tau217), glial fibrillary acidic protein (GFAP), neurofilament light chain (NfL), and total tau.

Time frame:
Baseline (Study Day 1) to Week 52
Reported as:
Mean · pg/mL
Changes From Baseline in Plasma Biomarkers
pg/mLSimufilam 100 mgPlacebo
P-tau2171.0 ± 6.56-0.4 ± 9.77
GFAP2.0 ± 57.3940.2 ± 255.14
NfL69.3 ± 373.4317.5 ± 96.73
Total tau5.5 ± 35.62-2.2 ± 41.98
Other pre-specifiedChanges From Baseline in the Plasma SavaDx Biomarker

Change from baseline in SavaDx, a novel plasma biomarker

Time frame:
Baseline (Study Day 1) to Week 52

No measurements were reported for this outcome.

Adverse events

Collected over Up to 54 weeks after subjects took their first dose of study drug, or until resolution or stabilization of any AEs ongoing at the end of the study.. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Simufilam 100 mg1/399 (0.3%)52/399 (13%)161/399 (40.4%)
Placebo3/398 (0.8%)36/398 (9%)140/398 (35.2%)
Most frequent serious events
Showing 10 of 92
Most frequent serious events
EventSimufilam 100 mgPlacebo
Hip fractureInjury, poisoning and procedural complications7/3991/398
SyncopeNervous system disorders4/3992/398
AstheniaGeneral disorders4/3991/398
Urinary tract infectionInfections and infestations2/3993/398
COVID-19Infections and infestations3/3991/398
Atrial fibrillationCardiac disorders3/3990/398
FallInjury, poisoning and procedural complications2/3992/398
Cerebrovascular accidentNervous system disorders0/3992/398
PresyncopeNervous system disorders0/3992/398
PneumoniaInfections and infestations2/3992/398
Most frequent other events
Showing 10 of 15
Most frequent other events
EventSimufilam 100 mgPlacebo
COVID-19Infections and infestations29/39935/398
FallInjury, poisoning and procedural complications30/39928/398
Urinary tract infectionInfections and infestations29/39927/398
DizzinessNervous system disorders21/3991/398
HeadacheNervous system disorders18/39911/398
DiarrhoeaGastrointestinal disorders16/39916/398
AnxietyPsychiatric disorders14/3999/398
DepressionPsychiatric disorders10/39911/398
FatigueGeneral disorders11/39911/398
Upper respiratory tract infectionInfections and infestations11/3998/398

Baseline characteristics

Age, Continuous
Age, Continuous(years)Simufilam 100 mgPlaceboTotal
Mean73.72 ± 7.91174.31 ± 7.55574.02 ± 7.737
Age, Customized
Age, Customized(Participants)Simufilam 100 mgPlaceboTotal
<65 years6247109
65 to 74 years126133259
≥75 years215221436
Sex: Female, Male
Sex: Female, Male(Participants)Simufilam 100 mgPlaceboTotal
Female225222447
Male178179357
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Simufilam 100 mgPlaceboTotal
Hispanic or Latino6251113
Not Hispanic or Latino334341675
Unknown or Not Reported7916
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Simufilam 100 mgPlaceboTotal
American Indian or Alaska Native011
Asian8210
Black or African American201838
Native Hawaiian or Other Pacific Islander213
White366376742
Other415
Multiple101
Not reported011
Unknown213
Region of Enrollment
Region of Enrollment(participants)Simufilam 100 mgPlaceboTotal
Canada312152
United States336355691
Australia362561
08

Study locations

88 sites
  • MDFirst Research
    Chandler, Arizona 85286, United States
  • CCT Research - Gilbert Neurology Partners
    Gilbert, Arizona 85297, United States
  • Xenoscience, Inc.
    Phoenix, Arizona 85004, United States
  • Advanced Research Center, Inc
    Anaheim, California 92805, United States
  • Axiom Research, LLC
    Colton, California 92324, United States
  • ATP Clinical Research, Inc.
    Costa Mesa, California 92626, United States
  • Sun Valley Research Center, Inc.
    Imperial, California 92251, United States
  • Senior Clinical Trials
    Laguna Hills, California 92653, United States
  • Artemis Institute for Clinical Research
    Riverside, California 92503, United States
  • Syrentis Clinical Research
    Santa Ana, California 92705, United States
  • Mountain Neurological Research Center
    Basalt, Colorado 81621, United States
  • Colorado Neurological Research Center, PC
    Denver, Colorado 80210, United States
  • CT Clinical Research
    Cromwell, Connecticut 06416, United States
  • Topaz Clinical Research
    Apopka, Florida 32703, United States
  • Neurology Offices of South Florida
    Boca Raton, Florida 33428, United States
  • Boynton Beach Medical Research Institute (GMI)
    Boynton Beach, Florida 33437, United States
  • K2 Medical Research - Clermont
    Clermont, Florida 34711, United States
  • Arrow Clinical Trials
    Daytona Beach, Florida 32117, United States
  • Neuropsychiatric Research Center of Southwest Florida
    Fort Myers, Florida 33912, United States
  • Velocity Clinical Research, Hallandale Beach
    Hallandale Beach, Florida 33009, United States
  • Galiz Research
    Hialeah, Florida 33016, United States
  • Infinity Clinical Research - Sunrise
    Hollywood, Florida 33024, United States
  • CNS Healthcare - Jacksonville
    Jacksonville, Florida 32256, United States
  • Charter Research
    Lady Lake, Florida 32162, United States
  • Segal Trials - West Broward Outpatient Site
    Lauderhill, Florida 33319, United States
  • ClinCloud
    Maitland, Florida 32751, United States
  • Merritt Island Medical Research, LLC
    Merritt Island, Florida 32952, United States
  • Quantam Clinical Trials
    Miami Beach, Florida 33140, United States
  • South Florida Research Phase I-IV INC
    Miami Springs, Florida 33166, United States
  • Central Miami Medical Institute (GMI)
    Miami, Florida 33125, United States
  • New Horizon Research Center
    Miami, Florida 33165, United States
  • Luminous Clinical Research
    Miami, Florida 33186, United States
  • Suncoast Clinical Research, Inc.
    New Port Richey, Florida 34652, United States
  • Renstar Medical Research
    Ocala, Florida 34470, United States
  • Charter Research
    Orlando, Florida 32803, United States
  • Combined Research Orlando Phase I-IV
    Orlando, Florida 32807, United States
  • Progressive Medical Research
    Port Orange, Florida 32127, United States
  • Clinical Research of Brandon, LLC (Tampa)
    Tampa, Florida 33603, United States
  • Stedman Clinical Trials
    Tampa, Florida 33613, United States
  • Premier Research Institute at Palm Beach Neurology
    West Palm Beach, Florida 33407, United States
  • Velocity Clinical Research, Boise
    Meridian, Idaho 83642, United States
  • Northwestern Medicine Central DuPage Hospital
    Winfield, Illinois 60190, United States
  • Ascension Via Christi Research
    Wichita, Kansas 67214, United States
  • Neuro Medical Clinic of Central Louisiana, LLC
    Alexandria, Louisiana 71301, United States
  • Boston Neuro Research Center
    North Dartmouth, Massachusetts 02747, United States
  • Clinical Research Professionals
    Chesterfield, Missouri 63005, United States
  • CCT Research - Papillion Research Center
    Papillion, Nebraska 68046, United States
  • Advanced Clinical Institute, Inc
    West Long Branch, New Jersey 07764, United States
  • Albuquerque Neuroscience, Inc
    Albuquerque, New Mexico 87109, United States
  • Dent Neurologic Institute
    Amherst, New York 14226, United States
  • Parker Jewish Institute for Health Care & Rehabilitation
    New Hyde Park, New York 11040-1433, United States
  • Mid Hudson Medical Research
    New Windsor, New York 12553, United States
  • NY Neurology Associates
    New York, New York 10003, United States
  • University of Rochester Medical Center - Alzheimer's Disease Care, Research and Education Program
    Rochester, New York 14620, United States
  • Five Town Neuroscience Research
    Woodmere, New York 11598, United States
  • Triad Clinical Trials, LLC
    Greensboro, North Carolina 27410, United States
  • Alzheimer's Memory Center
    Matthew, North Carolina 28105, United States
  • Insight Clinical Trials LLC
    Beachwood, Ohio 44122, United States
  • NeuroScience Research Center, LLC
    Canton, Ohio 44718, United States
  • Dayton Center for Neurological Disorders
    Centerville, Ohio 45459, United States
  • Summit Research Network, LLC
    Portland, Oregon 97210, United States
  • Brian Abaluck, LLC
    Malvern, Pennsylvania 19355, United States
  • Global Medical Institutes/Scranton Medical Institute - Moosic Division
    Moosic, Pennsylvania 18507, United States
  • Rhode Island Mood & Memory Research Institute
    East Providence, Rhode Island 02914, United States
  • Palmetto Clinical Research
    Summerville, South Carolina 29485, United States
  • FutureSearch Trials of Neurology
    Austin, Texas 78731, United States
  • Senior Adults Specialty Research, Inc
    Austin, Texas 78757, United States
  • Texas Neurology, PA
    Dallas, Texas 75206, United States
  • Baylor Scott & White Research Institute
    Dallas, Texas 75231, United States
  • Mt. Olympus Medical Research, LLC
    Katy, Texas 77450, United States
  • Grayline Research Center
    Wichita Falls, Texas 76309, United States
  • Green Mountain Research Institute, Inc.
    Rutland, Vermont 05701, United States
  • Re:Cognition Health
    Fairfax, Virginia 22031, United States
  • Memory and Brain Wellness Center at Harborview
    Seattle, Washington 98104, United States
  • KaRa MINDS
    Macquarie Park, New South Wales 2113, Australia
  • The University of Queensland
    Herston, Queensland 4029, Australia
  • Impact Health Pty Ltd.
    Southport, Queensland 4215, Australia
  • Eastern Health
    Box Hill, Victoria 3128, Australia
  • Delmont Private Hospital
    Glen Iris, Victoria 3146, Australia
  • Austin Health
    Heidelberg, Victoria 3084, Australia
  • The Alfred Hospital
    Melbourne, Victoria 3004, Australia
  • Royal Melbourne Hospital
    Parkville, Victoria 3050, Australia
  • Australian Alzheimer's Research Foundation
    Nedlands, Western Australia 8009, Australia
  • LMC Clinical Research - London
    London, Ontario N6A 5R9, Canada
  • Bluewater Clinical Research Group Inc
    Sarnia, Ontario N7T 4X3, Canada
  • Q & T Research
    Sherbrooke, Quebec J1J 2G2, Canada
  • Diex Research Sherbrooke Inc.
    Sherbrooke, Quebec J1L0H8, Canada
  • Alpha Recherche Clinique
    Québec, G3K 2P8, Canada
09

References and documents

Study documents

  • Study protocol · Jun 7, 2024
  • Statistical analysis plan · Oct 15, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04994483
Lead sponsor
Cassava Sciences, Inc.
Collaborators
Premier Research Group plc
Responsible party
Sponsor
First posted
Aug 6, 2021
Start date
Nov 3, 2021
Primary completion
Oct 2, 2024
Completion
Oct 2, 2024
Results posted
May 25, 2025
Last update
May 25, 2025

Study contacts

James Kupiec, MD
study chair · Cassava Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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