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ACTIVE NOT RECRUITING Phase 2

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. Master Protocol DIAN-TU-001

NCT01760005 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to assess the safety, tolerability, biomarker, cognitive and clinical efficacy of investigational products in participants with an Alzheimer's disease-causing mutation by determining if treatment with the study drug slows the rate of progression of cognitive/clinical impairment or improves disease-related biomarkers.

Interventions

  • DRUG Gantenerumab
  • DRUG Solanezumab
  • DRUG Matching Placebo (Gantenerumab)
  • DRUG Matching Placebo (Solanezumab)

Study Locations (20)

California

  • University of California San Diego Medical Center — La Jolla
  • USC Keck School of Medicine — Los Angeles

Other

  • Instituto de Investigaciones Neurologicas Raul Carrea, FLENI — Ciudad Autonoma de Buenos Aire
  • Hospital das Clínicas da Faculdade de Medicina da USP — São Paulo

Alabama

  • University of Alabama in Birmingham — Birmingham

Connecticut

  • Yale University School of Medicine — New Haven

Georgia

  • Emory University — Atlanta

Illinois

  • Advocate Lutheran General Hospital — Park Ridge

Indiana

  • Indiana University School of Medicine — Indianapolis

Missouri

  • Washington University in St. Louis — St Louis

Trial Details

FieldValue
Enrollment Target 490 participants
Start Date 2012-12
Est. Completion 2028-07
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01760005

The ClinicalTrials.gov registry entry for NCT01760005 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 490 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,036 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Dementia appearing as the primary indexed condition, and to 4 interventions — of which Gantenerumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01760005 reports 20 study locations spanning 18 distinct geographic areas — top geographies include California, Other, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01760005 about?

NCT01760005 is a clinical study titled "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. Master Protocol DIAN-TU-001". The purpose of this study is to assess the safety, tolerability, biomarker, cognitive and clinical efficacy of investigational products in participants with an Alzheimer's disease-causing mutation by determining if treatment with the study drug slows the rate of progression of cognitive/clinical imp...

What is the current status of trial NCT01760005?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 490 participants. The study started on 2012-12. Estimated completion is 2028-07.

What conditions does trial NCT01760005 study?

This clinical trial studies the following conditions: Dementia, Alzheimers Disease, Alzheimers Disease, Familial. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01760005?

The interventions under investigation include: Gantenerumab (DRUG), Solanezumab (DRUG), Matching Placebo (Gantenerumab) (DRUG), Matching Placebo (Solanezumab) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01760005?

This trial is sponsored by Washington University School of Medicine, which has 1,036 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01760005 being conducted?

This trial has 20 study locations across Alabama, California, Connecticut, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial