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. (DIAN-TU)
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ClinicalTrials.gov Identifier: NCT01760005 |
Recruitment Status :
Recruiting
First Posted : January 3, 2013
Last Update Posted : October 3, 2019
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The purpose of this study is to assess the safety, tolerability, biomarker and cognitive efficacy of investigational products in subjects who are known to have an Alzheimer's disease-causing mutation by determining if treatment with the study drug slows the rate of progression of cognitive impairment and improves disease-related biomarkers.
This study also offers an observational component collecting cognitive assessment data until the availability of an enrolling drug treatment group, referred to as cognitive run-in (CRI).
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimers Disease Dementia Alzheimers Disease, Familial | Drug: Gantenerumab Drug: Solanezumab Drug: Matching Placebo (Gantenerumab) Drug: Matching Placebo (Solanezumab) | Phase 2 Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 490 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Interventional with a non-interventional run-in component (Future interventions to be added) |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official 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 |
Study Start Date : | December 2012 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | March 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Gantenerumab |
Drug: Gantenerumab
Subcutaneously every 4 weeks at escalating doses
Other Name: RO4909832 |
Experimental: Solanezumab |
Drug: Solanezumab
Intravenous infusion every 4 weeks at escalating doses
Other Name: LY2062430 |
Placebo Comparator: Matching placebo (Gantenerumab) |
Drug: Matching Placebo (Gantenerumab)
Subcutaneous injection of placebo every 4 weeks |
Placebo Comparator: Matching Placebo (Solanezumab) |
Drug: Matching Placebo (Solanezumab)
Intravenous infusion of placebo every 4 weeks |
No Intervention: Cognitive Run-in (CRI) |
- Assess cognitive efficacy in individuals with mutations causing dominantly inherited AD as measured by change in the DIAN-TU cognitive composite score. [ Time Frame: Baseline and Weeks 52, 104, 156, and 208 ]
- Gantenerumab: Cerebral amyloid imaging using [11C]PiB-PET. [ Time Frame: Baseline and Weeks 52, 104, and 208 ]
- Solanezumab: Total Abeta 1-42 (Aβ42) in CSF. [ Time Frame: Baseline, Week 104 and Week 208 ]
- Change from Baseline in Clinical Measures [ Time Frame: Baseline, week 208 ]
- Clinical Dementia Rating (CDR), including CDR sum of boxes (CDR-SB) and clinician's diagnostic assessment
- Geriatric Depression Scale (GDS)
- Neuropsychiatric Inventory Questionnaire (NPI-Q)
- Functional Assessment Scale (FAS)
- Mini Mental Status Exam (MMSE)
- Change from Baseline in Cognitive Measures [ Time Frame: Baseline, week 208 ]
- International Shopping List Test (12-Item Word List Learning): 3 learning trials, Immediate Recall, 30-min Delayed Recall (CogState)
- Groton Maze Learning Test: Timed Chase Task, 5 learning Trials, Immediate Recall, 30-min Delayed Recall (CogState)
- Cogstate Detection Task
- Cogstate Identification Test
- Cogstate One Card Learning Test
- Cogstate One-Back (OBK) Task
- Behavioral Pattern Separation Object Task
- Memory Complaint Questionnaire (MAC-Q)
- Trails A & B
- Wechsler Memory Scale - Revised (WMS-R) Digit Span
- Wechsler Adult Intelligence Scale - Revised (WAIS-R) Digit-Symbol Substitution Test
- Raven's Progressive Matrices (Set A)
- Category Fluency (Animals & Vegetables)
- Wechsler Memory Scale Logical Memory I Paragraph Memory (Immediate & Delayed Recall)
- Safety and Tolerability Outcome Measures [ Time Frame: Baseline, week 208 ]
- Neurological findings
- Laboratory test results
- ECG findings
- Safety MRIs

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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 an autosomal dominant Alzheimer's disease (ADAD) mutation in their family.
- Are within -15 to + 10 years of the predicted or actual age of cognitive symptom onset for treatment arms. For Cognitive Run-In (CRI): includes participants who are younger than 15 years prior to the expected age of cognitive symptom onset, in addition to those 15 years younger and no more than 10 years older than expected 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.
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760005
Contact: Ellen Ziegemeier, MA | 844-DIANEXR (342-6397) | dianexr@wustl.edu | |
Contact: Jennifer Petranek | 844-DIANEXR (342-6397) | dianexr@wustl.edu |

Study Director: | Randall J Bateman, MD | Washington University School of Medicine |
Additional Information:
Publications:
Responsible Party: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT01760005 History of Changes |
Other Study ID Numbers: |
DIAN-TU-001 The Alzheimer's Association ( Other Grant/Funding Number: DIAN TTU-12-243040 ) U01AG042791 ( U.S. NIH Grant/Contract ) 2013-000307-17 ( EudraCT Number ) R01AG046179 ( U.S. NIH Grant/Contract ) REec-2014-0817 ( Registry Identifier: Spanish Clinical Studies Registry ) The Alzheimer's Association ( Other Grant/Funding Number: DIAN-TU Tau-15-347219 ) The Alzheimer's Association ( Other Grant/Funding Number: DIAN-TU NG-16-434362 ) R56AG053267 ( U.S. NIH Grant/Contract ) GHR Foundation ( Other Grant/Funding Number: File 4401 ) Alzheimer's Association ( Other Identifier: HDE 18S84914 ) U01AG059798 ( U.S. NIH Grant/Contract ) R01AG053267 ( U.S. NIH Grant/Contract ) |
First Posted: | January 3, 2013 Key Record Dates |
Last Update Posted: | October 3, 2019 |
Last Verified: | October 2019 |
Alzheimer's Alzheimer's Disease Dementia Mutation Genetic Mutation Dominantly Inherited Alzheimer's Disease |
Dominantly Inherited Alzheimer's Network Autosomal Dominant Alzheimer's Disease Early Onset Alzheimer's Disease DIAN DIAN-TU DIAN TU |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies |
Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |