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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04623242




Registration number
NCT04623242
Ethics application status
Date submitted
14/10/2020
Date registered
10/11/2020

Titles & IDs
Public title
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.
Scientific title
A Phase II/III Randomized, Double-Blind, Placebo-Controlled, Cognitive Endpoint, Multi-Center Study of Potential Disease Modifying Therapies in Individuals at Risk for and With Dominantly Inherited Alzheimer's Disease
Secondary ID [1] 0 0
The Alzheimer's Association
Secondary ID [2] 0 0
DIAN-TU-001 (gant-sola)
Universal Trial Number (UTN)
Trial acronym
DIAN-TU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimers Disease 0 0
Dementia 0 0
Alzheimers Disease, Familial 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Gantenerumab
Treatment: Drugs - Solanezumab
Treatment: Drugs - Matching Placebo (Gantenerumab)
Treatment: Drugs - Matching Placebo (Solanezumab)

Experimental: Gantenerumab -

Experimental: Solanezumab -

Placebo comparator: Matching placebo (Gantenerumab) -

Placebo comparator: Matching Placebo (Solanezumab) -


Treatment: Drugs: Gantenerumab
Subcutaneously every 4 weeks at escalating doses

Treatment: Drugs: Solanezumab
Intravenous infusion every 4 weeks at escalating doses

Treatment: Drugs: Matching Placebo (Gantenerumab)
Subcutaneous injection of placebo every 4 weeks

Treatment: Drugs: Matching Placebo (Solanezumab)
Intravenous infusion of placebo every 4 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assess Cognitive Efficacy in Individuals With Mutations Causing Dominantly Inherited AD as Measured by the DIAN-Multivariate Cognitive Endpoint (DIAN-MCE);
Timepoint [1] 0 0
Baseline through Week 260
Secondary outcome [1] 0 0
Gantenerumab: Rate of Change Over Time- Clinical Dementia Rating Sum of Boxes (CDR-SB)
Timepoint [1] 0 0
Baseline and Weeks 52, 104, 156, 208 and 260
Secondary outcome [2] 0 0
Gantenerumab: Rate of Change Over Time- Functional Assessment Scale (FAS)
Timepoint [2] 0 0
Baseline and Weeks 52, 104, 156, 208 and 260
Secondary outcome [3] 0 0
Gantenerumab: Imaging Measures Composite [11C] PiB Partial Volume Corrected Regional Spread Function Standardized Uptake Value Ratio - Composite
Timepoint [3] 0 0
Baseline, Weeks 52, 104 and 208
Secondary outcome [4] 0 0
Solanezumab: Clinical Measures- Clinical Dementia Rating (CDR)
Timepoint [4] 0 0
Baseline and Weeks 52, 104, 156, and 208
Secondary outcome [5] 0 0
Solanezumab: Clinical Measures- CDR Sum of Boxes (CDR-SB)
Timepoint [5] 0 0
Baseline and Weeks 52, 104, 156, and 208
Secondary outcome [6] 0 0
Solanezumab: Clinical Measures- Geriatric Depression Scale (GDS)
Timepoint [6] 0 0
Baseline and Weeks 52, 104, 156, 208 and 260
Secondary outcome [7] 0 0
Solanezumab: Clinical Measures- Neuropsychiatric Inventory Questionnaire (NPI-Q)
Timepoint [7] 0 0
Baseline and Weeks 52, 104, 156, 208 and 260
Secondary outcome [8] 0 0
Solanezumab: Clinical Measures- Functional Assessment Scale (FAS)
Timepoint [8] 0 0
Baseline and Weeks 52, 104, 156, 208 and 260
Secondary outcome [9] 0 0
Solanezumab: Clinical Measures- Mini-Mental Status State Examination (MMSE)
Timepoint [9] 0 0
Baseline and Weeks 52, 104, 156, 208 and 260
Secondary outcome [10] 0 0
Solanezumab: Cognitive Measures- International Shopping List Task 30-Minute Delayed Recall
Timepoint [10] 0 0
Baseline and Weeks 52, 104, 156, 208 and 260
Secondary outcome [11] 0 0
Solanezumab: Cognitive Measures- Groton Maze Learning Test 30 Minute Delayed Recall
Timepoint [11] 0 0
Baseline, Week 52, 104, 156, 208 and 260
Secondary outcome [12] 0 0
Solanezumab: Cognitive Measures- Groton Maze Learning Test Delayed Reversed Recall
Timepoint [12] 0 0
Baseline, Week 52, 104, 156, 208 and 260
Secondary outcome [13] 0 0
Solanezumab: Cognitive Measures- Trailmaking Test Part A
Timepoint [13] 0 0
Baseline and Weeks 52, 104, 156, 208 and 260
Secondary outcome [14] 0 0
Solanezumab: Cognitive Measures- Trailmaking Test Part B
Timepoint [14] 0 0
Baseline, Weeks 52, 104, 156, 208 and 260
Secondary outcome [15] 0 0
Solanezumab: Cognitive Measures- WAIS-R Digit-Symbol Substitution Test
Timepoint [15] 0 0
Baseline and Weeks 52, 104, 156, 208 and 260
Secondary outcome [16] 0 0
Solanezumab: Cognitive Measures- WMS-R Digit Span Backward
Timepoint [16] 0 0
Baseline and Weeks 52, 104, 156, 208 and 260
Secondary outcome [17] 0 0
Solanezumab: Cognitive Measures- WMS-R Digit Span Forward
Timepoint [17] 0 0
Baseline, Weeks 52, 104, 156, 208 and 260
Secondary outcome [18] 0 0
Solanezumab: Cognitive Measures- Raven's Progressive Matrices (Set A)
Timepoint [18] 0 0
Baseline and Weeks 52, 104, 156, 208 and 260
Secondary outcome [19] 0 0
Solanezumab: Cognitive Measures- Category Fluency (Animals)
Timepoint [19] 0 0
Baseline and Weeks 52, 104, 156, 208 and 260
Secondary outcome [20] 0 0
Solanezumab: Cognitive Measures- Category Fluency (Vegetables)
Timepoint [20] 0 0
Baseline and Weeks 52, 104, 156, 208 and 260
Secondary outcome [21] 0 0
Solanezumab: Cognitive Measures- WMS-R Logical Memory Delayed Recall Test
Timepoint [21] 0 0
Baseline and Weeks 52, 104, 156, 208 and 260
Secondary outcome [22] 0 0
Solanezumab: Cognitive Measures- WMS-R Logical Memory Immediate Recall Test
Timepoint [22] 0 0
Baseline and Weeks 52, 104, 156, 208 and 260
Secondary outcome [23] 0 0
Solanezumab: Cognitive Measures- Composite Including: Alternative Multivariate Composite: (1) Digit Span Backwards; (2) Logical Memory (Immediate); (3) Trailmaking B; (4) Category Fluency (Animals)
Timepoint [23] 0 0
Baseline through Week 260
Secondary outcome [24] 0 0
Solanezumab: Imaging Measures- Brain Amyloid Load as Measured by [11C]PiB-PET Non-partial Volume Corrected
Timepoint [24] 0 0
Baseline and Weeks 52, 104 and 208
Secondary outcome [25] 0 0
Solanezumab: Imaging Measures- Brain Amyloid Load as Measured by Florbetapir PET
Timepoint [25] 0 0
Weeks104 and 208
Secondary outcome [26] 0 0
Solanezumab: Imaging Measures- Brain Glucose Metabolism as Measured by Fluorodeoxyglucose (FDG)-PET Non-partial Volume Corrected
Timepoint [26] 0 0
Baseline and Weeks 52, 104 and 208
Secondary outcome [27] 0 0
Solanezumab: Imaging Measures- Brain Atrophy as Measured by Cortical Thickness of Regions of Interest - Precuneus Region
Timepoint [27] 0 0
Baseline and Weeks 52, 104, 156 and 208
Secondary outcome [28] 0 0
Solanezumab: Imaging Measures- Volumetric MRI Combined Total Volume Corrected for Head Size - Hippocampus Volume
Timepoint [28] 0 0
Baseline and Weeks 52, 104, 156, 208 and 260
Secondary outcome [29] 0 0
Solanezumab: Imaging Measures- Brain Tau Load as Measured by Flortaucipir PET Non-partial Volume Corrected
Timepoint [29] 0 0
Baseline and Weeks 52, 104 and 208
Secondary outcome [30] 0 0
Solanezumab: Imaging Measures- Brain Atrophy as Measured by Whole Brain Volume Corrected for Head Size
Timepoint [30] 0 0
Baseline and Weeks 52, 104, 156, 208 and 260
Secondary outcome [31] 0 0
Solanezumab: Imaging Measures- Brain Atrophy as Measured by Ventricular Volume (Volumetric MRI) Corrected for Head Size
Timepoint [31] 0 0
Baseline and Weeks 52, 104, 156, 208 and 260
Secondary outcome [32] 0 0
Solanezumab: Fluid Biomarker Measures- CSF Aß 40 Free Change From Baseline
Timepoint [32] 0 0
Baseline and Weeks 52, 104 and 208
Secondary outcome [33] 0 0
Solanezumab: Fluid Biomarker Measures- CSF Aß 42 Free
Timepoint [33] 0 0
Baseline and Weeks 52, 104 and 208
Secondary outcome [34] 0 0
Solanezumab: Fluid Biomarker Measures- CSF Tau
Timepoint [34] 0 0
Baseline and Weeks 52, 104 and 208
Secondary outcome [35] 0 0
Solanezumab: Fluid Biomarker Measures- CSF pTau 181
Timepoint [35] 0 0
Baseline and Weeks 52, 104 and 208
Secondary outcome [36] 0 0
Solanezumab: Change From Baseline Fluid Biomarker Measures- CSF Neurofilament Light Chain (NfL)
Timepoint [36] 0 0
Baseline and Weeks 52, 104 and 208
Secondary outcome [37] 0 0
Solanezumab: Fluid Biomarker Measures- Plasma Neurofilament Light Chain (NfL)
Timepoint [37] 0 0
Baseline and Weeks 52, 104 and 208
Secondary outcome [38] 0 0
Solanezumab: Fluid Biomarker Measures- Plasma Anti-drug Antibodies (ADA)
Timepoint [38] 0 0
Baseline and Weeks 52, 104 and 208
Secondary outcome [39] 0 0
Solanezumab: Fluid Biomarker Measures- Total Plasma Aß 1-40
Timepoint [39] 0 0
Baseline and Weeks 52, 104 and 208
Secondary outcome [40] 0 0
Solanezumab: Fluid Biomarker Measures- Total Plasma Aß 42
Timepoint [40] 0 0
Baseline and Weeks 52, 104 and 208
Secondary outcome [41] 0 0
Solanezumab: Fluid Biomarker Measures- CSF Aß 42 Total
Timepoint [41] 0 0
Baseline and Weeks 52, 104 and 208
Secondary outcome [42] 0 0
Solanezumab: Fluid Biomarker Measures- CSF Aß 40 Total
Timepoint [42] 0 0
Baseline and Weeks 52, 104 and 208

Eligibility
Key inclusion criteria
* Between 18-80 years of age
* Individuals who know they have an Alzheimer's disease-causing mutation or are unaware of their genetic status and have dominantly inherited Alzheimer's disease (DIAD) mutation in their family.
* Are within -15 to + 10 years of the predicted or actual age of cognitive symptom onset.
* Cognitively normal or with mild cognitive impairment or mild dementia, Clinical Dementia Rating (CDR) of 0-1 (inclusive)
* Fluency in DIAN-TU trial approved language and evidence of adequate premorbid intellectual functioning
* 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/03/2020
Sample size
Target
Accrual to date
Final
194
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Neuroscience Research Australia - Randwick
Recruitment hospital [2] 0 0
Mental Health Research Institute - Melbourne
Recruitment hospital [3] 0 0
The McCuster Foundation of Alzheimer's Disease Research - Nedlands
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
3010 - Melbourne
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Rhode Island
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
Canada
State/province [11] 0 0
British Columbia
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
France
State/province [14] 0 0
Haute Garonne
Country [15] 0 0
France
State/province [15] 0 0
Nord
Country [16] 0 0
France
State/province [16] 0 0
Paris
Country [17] 0 0
France
State/province [17] 0 0
Rhone
Country [18] 0 0
France
State/province [18] 0 0
Seine Maritime
Country [19] 0 0
Ireland
State/province [19] 0 0
Dublin
Country [20] 0 0
Puerto Rico
State/province [20] 0 0
San Juan
Country [21] 0 0
Spain
State/province [21] 0 0
Barcelona
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Greater London

Funding & Sponsors
Primary sponsor type
Other
Name
Washington University School of Medicine
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Eli Lilly and Company
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Hoffmann-La Roche
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Alzheimer's Association
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Government body
Name [4] 0 0
National Institute on Aging (NIA)
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Commercial sector/industry
Name [5] 0 0
Avid Radiopharmaceuticals
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Accelerating Medicines Partnership (AMP)
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Randall J Bateman, MD
Address 0 0
Washington University School of Medicine
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Access to DIAN-TU trial data will follow the DIAN-TU data access policy, which complies with the guidelines established by the Collaboration for Alzheimer's Prevention \[CAP REF\].

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04623242