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TerminatedPhase 2 / PHASE3Results posted

A Study of CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease

A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CNP520 in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease (AD).

Asset

Umibecestat

Listed sites

194

Recruiting sites

-

Enrollment

1,145

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Amyloid biomarker required (PET/CSF)•Study partner/caregiver required

Primary endpoints

•Event•Mini-Mental State Examination (MMSE)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Eudract number2016-002976-28
Org study IDCCNP520A2202J
NCT IDNCT03131453

Timeline

Milestones

Study first posted2017-04-27actual
Study start2017-08-03actual
Primary completion2020-03-26actual
Study completion2020-03-26actual
Last update posted2021-08-05actual
Results first posted2021-08-05actual

Assets

Drug assets

Umibecestat

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years
Maximum age75 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•consent to receive disclosure of their risk estimates to develop clinical symptoms of AD based on their APOE genotype and, if Heterozygotes, evidence of elevated brain amyloid.
•Male or female, age 60 to 75 years inclusive. Females must be considered post-menopausal and not of child bearing potential
•Cognitively unimpaired as evaluated by memory tests performed at screening.
•Participant's willingness to have a study partner.
•Carrier of at least one APOE4 gene if Heterozygotes, elevated brain amyloid (as measured by CSF Abeta or amyloid PET imaging)

Exclusion criteria

•Any disability that could have prevented the participants from completing all study requirements. -
•Current medical or neurological condition that could have impacted cognition or performance on cognitive assessments.
•Advanced, severe progressive or unstable disease that could have interfered with the safety, tolerability and study assessments, or put the participant at special risk.
•History of malignancy of any organ system, treated or untreated, within the past 60 months.
•Indication for, or current treatment with ChEIs and/or another AD treatment (e.g. memantine).
•Contraindication or intolerance to MRI.
•Brain MRI results showing findings unrelated to AD that, in the opinion of the Investigator might be a leading cause to future cognitive decline, could have posed a risk to the participant, or could have prevented a satisfactory MRI assessment for safety monitoring.
•Suicidal Ideation in the past six months, or Suicidal Behavior in the past two years.
•A positive drug screen at Screening, if, in the Investigator's opinion, was is due to drug abuse.
•Significantly abnormal laboratory results at Screening, not as a result of a temporary condition.
•Current clinically significant ECG findings.
•Clinically relevant depigmenting or hypopigmenting conditions (e.g. albinism, vitiligo) or active / history of chronic urticaria in the past year.

Endpoints (30)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition
8
Amyloid biomarkers
8
Memory
4
Neuroimaging
4
Behavior / neuropsychiatric
2
Tau biomarkers
2
Neurodegeneration biomarkers
2

Global cognition

8 endpoints
Primary/protocol endpoint

Time to Event (Diagnosis of Mild Cognitive Impairment or Dementia, Due to Alzheimer's Disease (AD))

Time frame:Baseline to last cognitive assessment performed (up to day 648)

time to event, event

Primary/protocol endpoint

Change in the Alzheimer's Prevention Initiative Composite Cognitive (APCC) Test Score

Time frame:Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Primary/registry result

Time to Event (Diagnosis of Mild Cognitive Impairment or Dementia, Due to Alzheimer's Disease (AD))

Time frame:Baseline to last cognitive assessment performed (up to day 648)

time to event, event

Posted result

GroupValue (number), probability of an eventReported bounds
CNP520 50 mgWeek 26 n=232,123,250n=232 Participants0.99-0.96 - 1.00
Week 52 n=52,24,57n=52 Participants0.97-0.94 - 0.99
Week 78 n=6,2,2n=6 Participants0.97-0.94 - 0.99
CNP520 15 mgWeek 26 n=232,123,250n=123 Participants1.00-1.00 - 1.00
Week 52 n=52,24,57n=24 Participants0.99-0.92 - 1.00
Week 78 n=6,2,2n=2 Participants0.99-0.92 - 1.00
PlaceboWeek 26 n=232,123,250n=250 Participants1.00-0.97 - 1.00
Week 52 n=52,24,57n=57 Participants0.99-0.96 - 1.00
Week 78 n=6,2,2n=2 Participants0.97-0.88 - 0.99
Primary/registry result

Change in the Alzheimer's Prevention Initiative Composite Cognitive (APCC) Test Score

Time frame:Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

GroupValue (mean), Total scoresStandard deviation
CNP520 50 mgWeek 26 n=160,79,162n=160 Participants-3.15.20
Last on-treatment n=269,144,275n=269 Participants-2.24.88
Last off-treatment n=255,124,260n=255 Participants-0.84.56
CNP520 15 mgWeek 26 n=160,79,162n=79 Participants-2.95.00
Last on-treatment n=269,144,275n=144 Participants-0.84.67
Last off-treatment n=255,124,260n=124 Participants-0.84.38
PlaceboWeek 26 n=160,79,162n=162 Participants-1.74.44
Last on-treatment n=269,144,275n=275 Participants-1.35.21
Last off-treatment n=255,124,260n=260 Participants-0.84.64
Secondary/protocol endpoint

Change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Score

Time frame:Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/protocol endpoint

Change in the Total and Index Scores of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Time frame:Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)

change from baseline, improvement

Secondary/registry result

Change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Score

Time frame:Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Posted result

GroupValue (mean), Scores on a scaleStandard deviation
CNP520 50 mgWeek 26 n=160,78,160n=160 Participants0.170.606
Last on-treatment n=265,144,267n=265 Participants0.150.557
Last off-treatment n=254,117,256n=254 Participants0.090.525
CNP520 15 mgWeek 26 n=160,78,160n=78 Participants0.200.451
Last on-treatment n=265,144,267n=144 Participants0.080.449
Last off-treatment n=254,117,256n=117 Participants0.070.401
PlaceboWeek 26 n=160,78,160n=160 Participants0.080.385
Last on-treatment n=265,144,267n=267 Participants0.100.468
Last off-treatment n=254,117,256n=256 Participants0.100.565
Secondary/registry result

Change in the Total and Index Scores of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Time frame:Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)

change from baseline, improvement

Posted result

GroupValue (mean), scoresStandard deviation
CNP520 50 mgTotal Week 26 n=162,81,162n=162 Participants-5.88.54
Total Last on-treatment n=356,183,353n=356 Participants-3.48.66
Total Last off-treatment n=259,125,265n=259 Participants-1.38.12
Immediate memory - Week 26 n=162,81,162n=162 Participants-9.811.85
Immediate memory - Last on-treatment n=347,183,353n=347 Participants-5.913.01
Immediate memory - Last off-treatment n=259,125,266n=259 Participants-3.112.50
Visuospatial Week 26 n=162,81,162n=162 Participants-5.615.11
Visuospatial Last on-treatment n=347,183,353n=347 Participants-3.714.90
Visuospatial Last off-treatment n=259,125,266n=259 Participants-1.514.87
Language Week 26 n=162,81,162n=162 Participants-0.811.48
Language Last on-treatment n=347,183,353n=347 Participants-0.311.95
Language Last off-treatment n=259,125,265n=259 Participants-1.010.93
Attention Week 26 n=162,81,162n=162 Participants0.111.19
Attention Last on-treatment n=347,183,353n=347 Participants0.011.30
Attention Last off-treatment n=259,125,265n=259 Participants1.611.59
Delayed memory - Week 26 n=162,81,162n=162 Participants-5.511.54
Delayed memory - Last on-treatment n=346,183,353n=346 Participants-3.011.58
Delayed memory - Last off-treatment n=259,125,265n=259 Participants-1.010.91
CNP520 15 mgTotal Week 26 n=162,81,162n=81 Participants-6.38.58
Total Last on-treatment n=356,183,353n=183 Participants-3.58.87
Total Last off-treatment n=259,125,265n=125 Participants-2.49.55
Immediate memory - Week 26 n=162,81,162n=81 Participants-9.712.10
Immediate memory - Last on-treatment n=347,183,353n=183 Participants-4.013.54
Immediate memory - Last off-treatment n=259,125,266n=125 Participants-4.813.52
Visuospatial Week 26 n=162,81,162n=81 Participants-5.415.51
Visuospatial Last on-treatment n=347,183,353n=183 Participants-3.815.14
Visuospatial Last off-treatment n=259,125,266n=125 Participants-0.714.37
Language Week 26 n=162,81,162n=81 Participants-1.811.05
Language Last on-treatment n=347,183,353n=183 Participants-1.711.69
Language Last off-treatment n=259,125,265n=125 Participants-2.012.68
Attention Week 26 n=162,81,162n=81 Participants-0.110.37
Attention Last on-treatment n=347,183,353n=183 Participants0.010.68
Attention Last off-treatment n=259,125,265n=125 Participants1.710.65
Delayed memory - Week 26 n=162,81,162n=81 Participants-5.011.68
Delayed memory - Last on-treatment n=346,183,353n=183 Participants-2.810.56
Delayed memory - Last off-treatment n=259,125,265n=125 Participants-2.510.34
PlaceboTotal Week 26 n=162,81,162n=162 Participants-3.48.35
Total Last on-treatment n=356,183,353n=353 Participants-0.58.88
Total Last off-treatment n=259,125,265n=265 Participants-1.98.56
Immediate memory - Week 26 n=162,81,162n=162 Participants-5.211.26
Immediate memory - Last on-treatment n=347,183,353n=353 Participants-1.113.04
Immediate memory - Last off-treatment n=259,125,266n=266 Participants-3.013.00
Visuospatial Week 26 n=162,81,162n=162 Participants-2.615.26
Visuospatial Last on-treatment n=347,183,353n=353 Participants-1.213.95
Visuospatial Last off-treatment n=259,125,266n=266 Participants-1.214.56
Language Week 26 n=162,81,162n=162 Participants-3.111.07
Language Last on-treatment n=347,183,353n=353 Participants-1.312.58
Language Last off-treatment n=259,125,265n=265 Participants-3.411.47
Attention Week 26 n=162,81,162n=162 Participants0.110.56
Attention Last on-treatment n=347,183,353n=353 Participants0.710.99
Attention Last off-treatment n=259,125,265n=265 Participants1.19.81
Delayed memory - Week 26 n=162,81,162n=162 Participants-2.111.69
Delayed memory - Last on-treatment n=346,183,353n=353 Participants0.811.43
Delayed memory - Last off-treatment n=259,125,265n=265 Participants-0.510.57

Memory

4 endpoints
Secondary/protocol endpoint

Change in the Everyday Cognition Scale (ECog-Subject) Total Scores

Time frame:Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)

change from baseline, improvement

Secondary/protocol endpoint

Change in the Everyday Cognition Scale (ECog-Informant) Total Scores

Time frame:Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)

change from baseline, improvement

Secondary/registry result

Change in the Everyday Cognition Scale (ECog-Subject) Total Scores

Time frame:Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)

change from baseline, improvement

Posted result

GroupValue (mean), Total scoresStandard deviation
CNP520 50 mgWeek 26 n=155,78,157n=155 Participants0.97.90
Last on-treatment n=266,143,268n=266 Participants1.68.03
Last off-treatment n=249,122,255n=249 Participants-0.16.49
CNP520 15 mgWeek 26 n=155,78,157n=78 Participants0.25.52
Last on-treatment n=266,143,268n=143 Participants0.45.62
Last off-treatment n=249,122,255n=122 Participants0.07.02
PlaceboWeek 26 n=155,78,157n=157 Participants0.56.76
Last on-treatment n=266,143,268n=268 Participants0.78.25
Last off-treatment n=249,122,255n=255 Participants0.17.47
Secondary/registry result

Change in the Everyday Cognition Scale (ECog-Informant) Total Scores

Time frame:Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)

change from baseline, improvement

Posted result

GroupValue (mean), Total scoresStandard deviation
CNP520 50 mgWeek 26 n=153,76,153n=153 Participants-0.37.55
Last on-treatment n=252,138,255n=252 Participants0.57.58
Last off-treatment n=223,113,239n=223 Participants0.56.97
CNP520 15 mgWeek 26 n=153,76,153n=76 Participants1.77.77
Last on-treatment n=252,138,255n=138 Participants0.78.49
Last off-treatment n=223,113,239n=113 Participants0.06.74
PlaceboWeek 26 n=153,76,153n=153 Participants-1.26.10
Last on-treatment n=252,138,255n=255 Participants0.27.00
Last off-treatment n=223,113,239n=239 Participants1.29.36

Behavior / neuropsychiatric

2 endpoints
Secondary/protocol endpoint

Number of Suicidal Ideation or Behavior Events

Time frame:Baseline up to study termination approximately 617 days

event count, event

Secondary/registry result

Number of Suicidal Ideation or Behavior Events

Time frame:Baseline up to study termination approximately 617 days

event count, event

Posted result

GroupValue (number), eventsReported bounds
CNP520 50 mgAny suicidal ideation n=13,3,9n=13 Participants25-
Any suicidal behavior n=1,0,1n=1 Participants1-
CNP520 15 mgAny suicidal ideation n=13,3,9n=3 Participants6-
PlaceboAny suicidal ideation n=13,3,9n=9 Participants12-
Any suicidal behavior n=1,0,1n=1 Participants1-

Amyloid biomarkers

8 endpoints
Secondary/protocol endpoint

Number of Participants With Newly Occurring Safety MRI Abnormalities (ARIA-E, ARIA-H,White Matter Disease and Any Other MRI Abnormalities)

Time frame:Baseline up to study termination approximately 617 days

event count, event

Secondary/protocol endpoint

Change in CSF Levels of Amyloid Beta 40 (Aβ40)

Time frame:Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)

change from baseline, improvement

Secondary/protocol endpoint

Change in CSF Levels of Amyloid Beta 42 (Aβ42)

Time frame:Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)

change from baseline, improvement

Secondary/protocol endpoint

Change in Amyloid Deposition as Measured by Standardized Uptake Ratio (SUVR) of Positron Emission Tomography (PET) Scan With Amyloid Radiotracer

Time frame:Baseline to Months 24 and 60

change from baseline, improvement

Secondary/registry result

Number of Participants With Newly Occurring Safety MRI Abnormalities (ARIA-E, ARIA-H,White Matter Disease and Any Other MRI Abnormalities)

Time frame:Baseline up to study termination approximately 617 days

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
CNP520 50 mgPresence of ARIA-Hn=455 Participants0-
Questionable presence of ARIA-En=455 Participants1-
White matter disease worsening: 1-3 increasen=455 Participants4-
White matter disease worsening: 4- - >8 increasen=455 Participants0-
White matter disease worsening >8n=455 Participants0-
Any other MRI abnormalitiesn=455 Participants1-
CNP520 15 mgPresence of ARIA-Hn=233 Participants0-
Questionable presence of ARIA-En=233 Participants0-
White matter disease worsening: 1-3 increasen=233 Participants2-
White matter disease worsening: 4- - >8 increasen=233 Participants0-
White matter disease worsening >8n=233 Participants0-
Any other MRI abnormalitiesn=233 Participants0-
PlaceboPresence of ARIA-Hn=456 Participants0-
Questionable presence of ARIA-En=456 Participants2-
White matter disease worsening: 1-3 increasen=456 Participants3-
White matter disease worsening: 4- - >8 increasen=456 Participants0-
White matter disease worsening >8n=456 Participants0-
Any other MRI abnormalitiesn=456 Participants1-
Secondary/registry result

Change in CSF Levels of Amyloid Beta 40 (Aβ40)

Time frame:Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)

change from baseline, improvement

Posted result

GroupValue (mean), ng/mLStandard deviation
CNP520 50 mgAB40 Last on-treatment n=1,0,1n=1 Participants-7.320-
AB40 Last off-treatment n=16,5,13n=16 Participants-1.4921.9263
PlaceboAB40 Last on-treatment n=1,0,1n=1 Participants-0.760-
AB40 Last off-treatment n=16,5,13n=13 Participants-1.1721.7408
CNP520 15 mgAB40 Last off-treatment n=16,5,13n=5 Participants0.8041.9220
Secondary/registry result

Change in CSF Levels of Amyloid Beta 42 (Aβ42)

Time frame:Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)

change from baseline, improvement

Posted result

GroupValue (mean), pg/mLStandard deviation
CNP520 50 mgAB42 Last on-treatment n=1,0,1n=1 Participants-366.200-
AB42 Last off-treatment n=16,5,13n=16 Participants20.43174.5595
PlaceboAB42 Last on-treatment n=1,0,1n=1 Participants-61.300-
AB42 Last off-treatment n=16,5,13n=13 Participants21.246104.3395
CNP520 15 mgAB42 Last off-treatment n=16,5,13n=5 Participants-68.66062.8505
Secondary/registry result

Change in Amyloid Deposition as Measured by Standardized Uptake Ratio (SUVR) of Positron Emission Tomography (PET) Scan With Amyloid Radiotracer

Time frame:Baseline to Months 24 and 60

change from baseline, improvement

Tau biomarkers

2 endpoints
Secondary/protocol endpoint

Change in CSF Levels of Total Tau and Phosphorylated Tau

Time frame:Baseline to Last on-treatment (Day 547) Baseline to Last off-treatment (Day 648)

change from baseline, improvement

Secondary/registry result

Change in CSF Levels of Total Tau and Phosphorylated Tau

Time frame:Baseline to Last on-treatment (Day 547) Baseline to Last off-treatment (Day 648)

change from baseline, improvement

Posted result

GroupValue (mean), pg/mLStandard deviation
CNP520 50 mgTotal tau - Last on-treatment n=1,0,1n=1 Participants40.000-
Total tau - Last off-treatment n=16,5,13n=16 Participants-22.11928.6218
Phosphorylated tau - Last on-treatment n=1,0,1n=1 Participants-2.360-
Phosphorylated tau - Last off-treatment n=16,5,13n=16 Participants-1.8492.3397
PlaceboTotal tau - Last on-treatment n=1,0,1n=1 Participants-12.600-
Total tau - Last off-treatment n=16,5,13n=13 Participants-3.23823.4442
Phosphorylated tau - Last on-treatment n=1,0,1n=1 Participants-0.550-
Phosphorylated tau - Last off-treatment n=16,5,13n=13 Participants0.0651.3032
CNP520 15 mgTotal tau - Last off-treatment n=16,5,13n=5 Participants-3.32021.1548
Phosphorylated tau - Last off-treatment n=16,5,13n=5 Participants-0.8522.7005

Neurodegeneration biomarkers

2 endpoints
Secondary/protocol endpoint

Change in Serum Neurofilaments

Time frame:Baseline to Week 26, baseline to Last on-treatment (Day 547) Baseline to Last off-treatment (Day 648)

Neurofilament light (NfL)

change from baseline, improvement

Secondary/registry result

Change in Serum Neurofilaments

Time frame:Baseline to Week 26, baseline to Last on-treatment (Day 547) Baseline to Last off-treatment (Day 648)

Neurofilament light (NfL)

change from baseline, improvement

Posted result

GroupValue (mean), pg/mLStandard deviation
CNP520 50 mgWeek 26 n=33,17,38n=33 Participants0.6224.5576
Last on-treatment n=33,15,40n=33 Participants0.9324.2494
Last off-treatment n=5,2,1n=5 Participants-2.7643.0981
CNP520 15 mgWeek 26 n=33,17,38n=17 Participants0.9014.6732
Last on-treatment n=33,15,40n=15 Participants0.0413.4144
Last off-treatment n=5,2,1n=2 Participants7.3509.5884
PlaceboWeek 26 n=33,17,38n=38 Participants-5.73140.9042
Last on-treatment n=33,15,40n=40 Participants-5.77139.8254
Last off-treatment n=5,2,1n=1 Participants3.880-

Neuroimaging

4 endpoints
Secondary/protocol endpoint

Annualized Percent Change on Volume of Brain Regions

Time frame:Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Neurofibrillary Tangle Burden as Measured by Standardized Uptake Ratio (SUVR) of PET Scans With Tau Radiotracer (Where Available)

Time frame:Baseline to Months 24 and 60

change from baseline, improvement

Secondary/registry result

Annualized Percent Change on Volume of Brain Regions

Time frame:Baseline to Week 26, Baseline to Last on-treatment (Day 547) and Baseline to Last off-treatment (Day 648)

percent change from baseline, improvement

Posted result

GroupValue (mean), Percentage of volume changeStandard deviation
CNP520 50 mgWB Week 26 n=169,83,169n=169 Participants-1.10161.03196
WB Last on-treatment n=179,85,182n=179 Participants-1.04270.93751
WB Last off-treatment n=72,44,81n=72 Participants-0.69840.73644
Hip Week 26 n=169,83,169n=169 Participants-2.09932.77159
Hip Last on-treatment n=179,85,182n=179 Participants-2.00522.65898
Hip Last off-treatment n=72,44,81n=72 Participants-1.37551.90613
LV Week 26 n=169,83,169n=169 Participants5.43885.91870
LV Last on-treatment n=179,85,182n=179 Participants5.09745.31542
LV Last off-treatment n=72,44,81n=72 Participants4.00144.29087
CNP520 15 mgWB Week 26 n=169,83,169n=83 Participants-0.93480.85477
WB Last on-treatment n=179,85,182n=85 Participants-0.92050.75633
WB Last off-treatment n=72,44,81n=44 Participants-0.91880.94516
Hip Week 26 n=169,83,169n=83 Participants-1.91002.31406
Hip Last on-treatment n=179,85,182n=85 Participants-1.79092.06883
Hip Last off-treatment n=72,44,81n=44 Participants-1.25222.23213
LV Week 26 n=169,83,169n=83 Participants5.34574.67788
LV Last on-treatment n=179,85,182n=85 Participants5.08223.88165
LV Last off-treatment n=72,44,81n=44 Participants3.93555.17657
PlaceboWB Week 26 n=169,83,169n=169 Participants-0.55521.21385
WB Last on-treatment n=179,85,182n=182 Participants-0.53781.09542
WB Last off-treatment n=72,44,81n=81 Participants-0.58110.75412
Hip Week 26 n=169,83,169n=169 Participants-1.21132.71764
Hip Last on-treatment n=179,85,182n=182 Participants-1.16282.56183
Hip Last off-treatment n=72,44,81n=81 Participants-1.19291.81333
LV Week 26 n=169,83,169n=169 Participants3.54154.75268
LV Last on-treatment n=179,85,182n=182 Participants3.45824.35888
LV Last off-treatment n=72,44,81n=81 Participants3.38513.38576
Secondary/registry result

Change in Neurofibrillary Tangle Burden as Measured by Standardized Uptake Ratio (SUVR) of PET Scans With Tau Radiotracer (Where Available)

Time frame:Baseline to Months 24 and 60

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.