DIAN-TU

TerminatedPhase 2 / PHASE3Results posted

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia: A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation

A Phase II/III Multicenter Randomized, Double-Blind, Placebo-Controlled Platform Trial of Potential Disease Modifying Therapies Utilizing Biomarker, Cognitive, and Clinical Endpoints in Dominantly Inherited Alzheimer's Disease

Lead sponsor

Washington University School of Medicine

Asset

Gantenerumab

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Study partner/caregiver required

Primary endpoint

•Composite [11C] Pittsburgh Compound B (PiB)-Positron Emission Tomography (PET)

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

Org study IDDIAN-TU-001 (Gant OLE)

NCT IDNCT06424236

Timeline

Milestones

Study start2020-06-03actual

Primary completion2023-10-06actual

Study completion2023-11-13actual

Study first posted2024-05-22actual

Last update posted2025-02-04actual

Results first posted2025-02-04actual

Assets

Drug assets

Gantenerumab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Between 18-80 years of age

•Individuals who know they have an Alzheimer's disease-causing mutation

•Individuals who have participated in the double-blind period

•In the opinion of the investigator and sponsor, treatment is not contraindicated for safety

•Capable of receiving drug and appropriate clinical safety assessment

•Able to undergo Magnetic Resonance Imaging (MRI), Lumbar Puncture (LP), Positron Emission Tomography (PET), and complete all study related testing and evaluations.

•For women of childbearing potential, if partner is not sterilized, subject must agree to use effective contraceptive measures (hormonal contraception, intra-uterine device, sexual abstinence, barrier method with spermicide).

•Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments.

•Has a Study Partner who in the investigator's judgment is able to provide accurate information as to the subject's cognitive and functional abilities, who agrees to provide information at the study visits which require informant input for scale completion

Exclusion criteria

•History or presence of brain MRI scans indicative of any other significant abnormality

•Alcohol or drug dependence currently or within the past 1 year

•Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin or body which would preclude MRI scan.

•History or presence of clinically significant cardiovascular disease, hepatic/renal disorders, infectious disease or immune disorder, or metabolic/endocrine disorders

•Anticoagulants except low dose (≤ 325 mg) aspirin.

•Have been exposed to a monoclonal antibody targeting beta amyloid peptide within the past six months.

•History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years.

•Positive urine or serum pregnancy test or plans or desires to become pregnant during the course of the trial.

•Subjects unable to complete all study related testing, including implanted metal that cannot be removed for MRI scanning, required anticoagulation and pregnancy.

Endpoints (20)

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

Disease progression

Function / daily living

Amyloid biomarkers

Global cognition

8 endpoints

Secondary/protocol endpoint

Change From Baseline in Clinical Dementia Rating (CDR) - Sum of Boxes Score at Weeks 52, 104 and 156

Time frame:Baseline (Day 1) and Weeks 52, 104 and 156

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

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Clinical Dementia Rating - Global Score at Weeks 52, 104 and 156

Time frame:Baseline (Day 1) and Weeks 52, 104 and 156

change from baseline, improvement

Secondary/registry result

Change From Baseline in Clinical Dementia Rating (CDR) - Sum of Boxes Score at Weeks 52, 104 and 156

Time frame:Baseline (Day 1) and Weeks 52, 104 and 156

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

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Double-blind Placebo - OLE GantenerumabWeek 52n=17 Participants	1.12	2.147
Week 104n=15 Participants	1.47	2.191
Week 156n=10 Participants	2.15	3.504
Double-blind Solanezumab - OLE GantenerumabWeek 52n=23 Participants	0.91	1.497
Week 104n=21 Participants	1.31	2.507
Week 156n=10 Participants	0.40	0.907
Double-blind Gantenerumab - OLE GantenerumabWeek 52n=22 Participants	0.09	0.666
Week 104n=22 Participants	0.50	1.504
Week 156n=14 Participants	1.14	2.405

Hazard Ratio (HR)1.3295% CI0.64 - 2.70p0.4535Regression, Cox

Hazard Ratio (HR)1.1895% CI0.74 - 1.86p0.4848Regression, Cox

Secondary/registry result

Change From Baseline in Clinical Dementia Rating - Global Score at Weeks 52, 104 and 156

Time frame:Baseline (Day 1) and Weeks 52, 104 and 156

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Double-blind Placebo - OLE GantenerumabWeek 52n=17 Participants	0.12	0.281
Week 104n=15 Participants	0.17	0.309
Week 156n=10 Participants	0.25	0.425
Double-blind Solanezumab - OLE GantenerumabWeek 52n=23 Participants	0.17	0.324
Week 104n=21 Participants	0.21	0.514
Week 156n=10 Participants	0.10	0.211
Double-blind Gantenerumab - OLE GantenerumabWeek 52n=22 Participants	0.02	0.188
Week 104n=22 Participants	0.09	0.366
Week 156n=14 Participants	0.18	0.421

Hazard Ratio (HR)0.9395% CI0.33 - 2.58p0.8855Regression, Cox

Hazard Ratio (HR)0.7295% CI0.30 - 1.69p0.4497Regression, Cox

Secondary/protocol endpoint

Change From Baseline in Mini-Mental State Examination (MMSE) at Weeks 24, 52, 76, 104, 128 and 156

Time frame:Baseline (Day 1) and Weeks 24, 52, 76, 104, 128 and 156

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Mini-Mental State Examination (MMSE) at Weeks 24, 52, 76, 104, 128 and 156

Time frame:Baseline (Day 1) and Weeks 24, 52, 76, 104, 128 and 156

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Double-blind Placebo - OLE GantenerumabWeek 24n=17 Participants	-0.6	2.40
Week 52n=17 Participants	-1.2	2.74
Week 76n=16 Participants	-2.1	3.70
Week 104n=15 Participants	-3.1	5.13
Week 128n=11 Participants	-3.3	5.50
Week 156n=8 Participants	-3.8	7.61
Double-blind Solanezumab - OLE GantenerumabWeek 24n=22 Participants	-0.5	3.00
Week 52n=24 Participants	-1.0	2.47
Week 76n=22 Participants	-0.8	3.51
Week 104n=21 Participants	-1.5	4.73
Week 128n=14 Participants	-0.2	1.93
Week 156n=6 Participants	1.2	1.33
Double-blind Gantenerumab - OLE GantenerumabWeek 24n=24 Participants	-0.1	1.23
Week 52n=24 Participants	-0.9	2.35
Week 76n=23 Participants	-0.9	2.89
Week 104n=24 Participants	-1.2	3.53
Week 128n=19 Participants	-2.1	4.71
Week 156n=12 Participants	-1.4	3.92

LS mean0.0095% CI-0.43 - 0.44p0.989Linear Mixed Effects Model

LS mean0.2095% CI-0.86 - 1.25p0.714Linear Mixed Effects Model

Secondary/protocol endpoint

Change From Baseline in DIAN-TU Open Label Extension Cognitive Composite Score at Weeks 52, 104 and 156

Time frame:Baseline (Day 1) and Weeks 52, 104 and 156

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Change From Baseline in DIAN-TU Open Label Extension Cognitive Composite Score at Weeks 52, 104 and 156

Time frame:Baseline (Day 1) and Weeks 52, 104 and 156

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Double-blind Placebo - OLE GantenerumabWeek 52n=17 Participants	-0.2281	0.44682
Week 104n=15 Participants	-0.5535	0.82376
Week 156n=9 Participants	-0.3309	0.60877
Double-blind Solanezumab - OLE GantenerumabWeek 52n=22 Participants	-0.1462	0.37510
Week 104n=21 Participants	-0.2373	0.49333
Week 156n=8 Participants	-0.2738	0.49439
Double-blind Gantenerumab - OLE GantenerumabWeek 52n=23 Participants	-0.1336	0.26523
Week 104n=23 Participants	-0.2493	0.48045
Week 156n=12 Participants	-0.1327	0.31666

LS mean0.0495% CI-0.12 - 0.20p0.644Linear Mixed Effects Model

LS mean0.0495% CI-0.18 - 0.26p0.745Linear Mixed Effects Model

Function / daily living

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Functional Assessment Scale (FAS) at Weeks 52, 104 and 156

Time frame:Baseline (Day 1) and Weeks 52, 104 and 156

change from baseline, improvement

Secondary/registry result

Change From Baseline in Functional Assessment Scale (FAS) at Weeks 52, 104 and 156

Time frame:Baseline (Day 1) and Weeks 52, 104 and 156

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Double-blind Placebo - OLE GantenerumabWeek 52n=15 Participants	1.7555	3.25466
Week 104n=14 Participants	3.1885	5.48051
Week 156n=9 Participants	2.1944	3.37680
Double-blind Solanezumab - OLE GantenerumabWeek 52n=22 Participants	1.1060	2.80472
Week 104n=21 Participants	1.9524	3.85326
Week 156n=8 Participants	1.0000	2.39046
Double-blind Gantenerumab - OLE GantenerumabWeek 52n=23 Participants	0.4348	1.67403
Week 104n=23 Participants	0.8889	2.71006
Week 156n=13 Participants	1.6154	3.37980

LS mean-0.0695% CI-0.46 - 0.33p0.760Linear Mixed Effects Model

LS mean-1.2195% CI-2.63 - 0.20p0.093Linear Mixed Effects Model

Disease progression

8 endpoints

Secondary/protocol endpoint

Change From Baseline in Tau Positron Emission Tomography Binding Partial Volume Corrected Standardized Uptake Value Ratio (Tau PET SUVR) at Weeks 52, 104 and 156

Time frame:Baseline (Day 1) and Weeks 52, 104 and 156

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Phosphorylated Tau (pTau)-181 in Cerebrospinal Fluid (CSF) at Weeks 52, 104 and 156

Time frame:Baseline (Day 1) and Weeks 52, 104 and 156

change from baseline, improvement

Secondary/registry result

Change From Baseline in Tau Positron Emission Tomography Binding Partial Volume Corrected Standardized Uptake Value Ratio (Tau PET SUVR) at Weeks 52, 104 and 156

Time frame:Baseline (Day 1) and Weeks 52, 104 and 156

change from baseline, improvement

Posted result

Group	Value (mean), ratio	Standard deviation
Double-blind Placebo - OLE GantenerumabWeek 52n=11 Participants	0.09032	0.337016
Week 104n=12 Participants	0.29471	0.658922
Week 156n=3 Participants	0.38857	0.475259
Double-blind Solanezumab - OLE GantenerumabWeek 52n=13 Participants	-0.11554	0.537111
Week 104n=14 Participants	0.19329	0.811715
Week 156n=4 Participants	-0.02390	0.860703
Double-blind Gantenerumab - OLE GantenerumabWeek 52n=13 Participants	0.12246	0.202397
Week 104n=16 Participants	0.26572	0.314147
Week 156n=8 Participants	0.21449	0.281091

LS mean-0.0395% CI-0.18 - 0.13p0.738Linear Mixed Effects Model

LS mean0.1995% CI-0.28 - 0.66p0.395Linear Mixed Effects Model

Secondary/protocol endpoint

Change From Baseline in Neurofilament Light Chain (NfL) in Cerebrospinal Fluid at Weeks 52, 104 and 156

Time frame:Baseline (Day 1) and Weeks 52, 104 and 156

Neurofilament light (NfL)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Phosphorylated Tau (pTau)-181 in Cerebrospinal Fluid (CSF) at Weeks 52, 104 and 156

Time frame:Baseline (Day 1) and Weeks 52, 104 and 156

change from baseline, improvement

Posted result

Group	Value (mean), picogram per milliliter (pg/mL)	Standard deviation
Double-blind Placebo - OLE GantenerumabWeek 52n=17 Participants	-3.29012	3.301052
Week 104n=15 Participants	-7.15305	5.152265
Week 156n=9 Participants	-8.13416	5.861080
Double-blind Solanezumab - OLE GantenerumabWeek 52n=19 Participants	-2.95397	3.225444
Week 104n=20 Participants	-6.03388	4.745042
Week 156n=9 Participants	-6.83542	3.548298
Double-blind Gantenerumab - OLE GantenerumabWeek 52n=21 Participants	-0.28807	1.740518
Week 104n=21 Participants	-1.19673	2.262092
Week 156n=13 Participants	-1.48436	2.746503

LS mean-2.176095% CI-2.9469 - -1.4051p<0.0001MMRM

LS mean-4.843495% CI-5.8609 - -3.8260p<0.0001MMRM

LS mean-5.762095% CI-6.9679 - -4.5561p<0.0001MMRM

Secondary/protocol endpoint

Change From Baseline in Amyloid Beta1-42/40 Ratio in Cerebrospinal Fluid at Weeks 52, 104 and 156

Time frame:Baseline (Day 1) and Weeks 52, 104 and 156

change from baseline, improvement

Secondary/registry result

Change From Baseline in Neurofilament Light Chain (NfL) in Cerebrospinal Fluid at Weeks 52, 104 and 156

Time frame:Baseline (Day 1) and Weeks 52, 104 and 156

Neurofilament light (NfL)

change from baseline, improvement

Posted result

Group	Value (mean), pg/mL	Standard deviation
Double-blind Placebo - OLE GantenerumabWeek 52n=16 Participants	176.01	223.432
Week 104n=15 Participants	263.74	268.343
Week 156n=9 Participants	233.30	186.805
Double-blind Solanezumab - OLE GantenerumabWeek 52n=19 Participants	283.97	255.009
Week 104n=20 Participants	351.02	312.203
Week 156n=8 Participants	609.45	549.253
Double-blind Gantenerumab - OLE GantenerumabWeek 52n=21 Participants	106.09	252.328
Week 104n=20 Participants	257.12	255.528
Week 156n=13 Participants	402.20	536.504

LS mean0.0495% CI0.00 - 0.09p0.055Linear Mixed Effects Model

LS mean0.0495% CI-0.02 - 0.11p0.188Linear Mixed Effects Model

Secondary/registry result

Change From Baseline in Amyloid Beta1-42/40 Ratio in Cerebrospinal Fluid at Weeks 52, 104 and 156

Time frame:Baseline (Day 1) and Weeks 52, 104 and 156

change from baseline, improvement

Posted result

Group	Value (mean), ratio	Standard deviation
Double-blind Placebo - OLE GantenerumabWeek 52n=17 Participants	0.00669	0.015517
Week 104n=15 Participants	0.02961	0.022677
Week 156n=9 Participants	0.04400	0.024807
Double-blind Solanezumab - OLE GantenerumabWeek 52n=19 Participants	0.01217	0.013657
Week 104n=20 Participants	0.03588	0.025329
Week 156n=9 Participants	0.05304	0.037927
Double-blind Gantenerumab - OLE GantenerumabWeek 52n=21 Participants	-0.00060	0.008280
Week 104n=20 Participants	0.00571	0.010013
Week 156n=12 Participants	0.01182	0.022581

LS mean0.006795% CI0.0034 - 0.0100p0.0001MMRM

LS mean0.025195% CI0.0189 - 0.0312p<0.0001MMRM

LS mean0.035795% CI0.0266 - 0.0447p<0.0001MMRM

Amyloid biomarkers

2 endpoints

Primary/protocol endpoint

Change From Baseline in Composite [11C] Pittsburgh Compound B (PiB)-Positron Emission Tomography (PET) Composite Standardized Uptake Value Ratio (C-SUVR) at Weeks 52, 104 and 156

Time frame:Baseline (Day 1) and Weeks 52, 104 and 156

change from baseline, improvement

Primary/registry result

Change From Baseline in Composite [11C] Pittsburgh Compound B (PiB)-Positron Emission Tomography (PET) Composite Standardized Uptake Value Ratio (C-SUVR) at Weeks 52, 104 and 156

Time frame:Baseline (Day 1) and Weeks 52, 104 and 156

change from baseline, improvement

Posted result

Group	Value (mean), ratio	Standard deviation
Double-blind Placebo - OLE GantenerumabWeek 52n=12 Participants	-0.1382	0.22606
Week 104n=10 Participants	-0.4843	0.55217
Week 156n=6 Participants	-0.7660	0.64108
Double-blind Solanezumab - OLE GantenerumabWeek 52n=18 Participants	-0.3318	0.40538
Week 104n=20 Participants	-0.7026	0.63641
Week 156n=9 Participants	-1.1761	0.96831
Double-blind Gantenerumab - OLE GantenerumabWeek 52n=14 Participants	0.1201	0.15142
Week 104n=20 Participants	-0.1880	0.26639
Week 156n=10 Participants	-0.2748	0.41027

Least square (LS) mean-0.116695% CI-0.2060 - -0.0272p0.0117Mixed Model for Repeated Measures (MMRM)

LS mean-0.464895% CI-0.5971 - -0.3326p<0.0001MMRM

LS mean-0.706295% CI-0.8821 - -0.5303p<0.0001MMRM

Publications (13)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.