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History of Changes for Study: NCT03828747
A Study of MTAU9937A in Patients With Moderate Alzheimer's Disease
Latest version (submitted February 28, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 31, 2019 None (earliest Version on record)
2 February 13, 2019 Arms and Interventions, Study Status, Contacts/Locations, Outcome Measures, Study Description and Study Identification
3 February 25, 2019 Arms and Interventions, Outcome Measures, Study Description, Study Status and Study Identification
4 March 11, 2019 Study Status and Contacts/Locations
5 April 1, 2019 Contacts/Locations and Study Status
6 April 22, 2019 Contacts/Locations, IPDSharing and Study Status
7 May 13, 2019 Contacts/Locations and Study Status
8 June 12, 2019 Contacts/Locations and Study Status
9 July 1, 2019 Study Status, Contacts/Locations and Arms and Interventions
10 July 22, 2019 Contacts/Locations and Study Status
11 August 12, 2019 Study Status and Contacts/Locations
12 September 4, 2019 Study Status
13 October 7, 2019 Study Status and Contacts/Locations
14 October 30, 2019 Arms and Interventions, Study Description, Study Status and Study Identification
15 November 1, 2019 Study Status
16 November 25, 2019 Contacts/Locations and Study Status
17 December 16, 2019 Study Status
18 January 6, 2020 Study Status and Contacts/Locations
19 February 4, 2020 Study Status
20 March 17, 2020 Contacts/Locations and Study Status
21 April 6, 2020 Study Status and Contacts/Locations
22 May 7, 2020 Outcome Measures, Study Status, Contacts/Locations and Study Description
23 June 8, 2020 Contacts/Locations and Study Status
24 July 27, 2020 Contacts/Locations and Study Status
25 August 17, 2020 Study Status
26 September 9, 2020 Study Status
27 October 5, 2020 Study Status
28 October 12, 2020 Recruitment Status, Contacts/Locations and Study Status
29 November 3, 2020 Study Status
30 February 1, 2021 Study Status
31 April 26, 2021 Study Status and Contacts/Locations
32 July 22, 2021 Contacts/Locations and Study Status
33 October 18, 2021 Contacts/Locations, Study Status and Study Design
34 January 13, 2022 Study Status and Contacts/Locations
35 February 28, 2022 Outcome Measures, Study Status, Arms and Interventions, Study Design and Study Description
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Study NCT03828747
Submitted Date:  January 31, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: GN40040
Brief Title: A Study of MTAU9937A in Patients With Moderate Alzheimer's Disease
Official Title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of MTAU9937A in Patients With Moderate Alzheimer's Disease
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2019
Overall Status: Recruiting
Study Start: February 28, 2019
Primary Completion: September 24, 2021 [Anticipated]
Study Completion: September 24, 2021 [Anticipated]
First Submitted: January 29, 2019
First Submitted that
Met QC Criteria:
January 31, 2019
First Posted: February 4, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
January 31, 2019
Last Update Posted: February 4, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Genentech, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the clinical efficacy, safety, pharmacokinetics, and pharmacodynamics of MTAU9937A in patients with moderate AD. The study consists of a screening period, a double-blind treatment period, an optional open-label extension (OLE) period, and a safety follow-up period.
Detailed Description:
Open or close this module Conditions
Conditions: Alzheimer's Disease
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 260 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: MTAU9937A
MTAU9937A will be administered intravenously in the double-blind treatment period, and MTAU9937A will be administered in the optional open-label extension period.
Drug: MTAU9937A
Participants will receive MTAU9937A every 2 weeks (Q2W) for the first three doses of the double-blind treatment period and every 4 weeks (Q4W) thereafter during the double-blind treatment period. MTAU9937A will be administered Q4W in the OLE period.
Drug: [18F]GTP1
[18F]GTP1 will be administered as a solution for intravenous (IV) use, as part of positron emission tomography (PET) imaging.
Placebo Comparator: Placebo
Placebo will be administered intravenously in the double-blind treatment period.
Drug: Placebo
Participants will placebo every 2 weeks (Q2W) for the first three doses of the double-blind treatment period and every 4 weeks (Q4W) thereafter during the double-blind treatment period.
Drug: [18F]GTP1
[18F]GTP1 will be administered as a solution for intravenous (IV) use, as part of positron emission tomography (PET) imaging.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Change from baseline to Week 49 in cognitive function as measured by the Alzheimer's Disease Assessment Scale, Cognitive Subscale, 11-item version (ADAS-Cog11)
[ Time Frame: Baseline to Week 49 ]

A 70-point scale used to quantify the areas of cognitive function most often affected in Alzheimer's disease. Lower scores indicate better cognitive function.
2. Change from baseline to Week 49 in functional capacities as measured by the Alzheimer's Disease Cooperative Study-Daily Living Inventory (ADCS-ADL)
[ Time Frame: Baseline to Week 49 ]

A scale used to quantify performance of activities of daily living. Scores on the ADCS-ADL range from 0-78, with higher scores indicating better ADL function.
Secondary Outcome Measures:
1. Change from baseline to Week 49 on the Clinical Dementia Rating-Sum of Boxes (CDR-SB)
[ Time Frame: Baseline to Week 49 ]

A scale used to quantify the severity of symptoms of dementia. The CDR-SB is obtained through interviews of patients and informants, and disease severity is rated in 6 domains of functioning: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on a 5-point scale of functioning as follows: 0, no impairment; 0.5, questionable impairment; 1, mild impairment; 2, moderate impairment; and 3, severe impairment (personal care is scored on a 4-point scale without a 0.5 rating available). The CDR-SOB score is obtained by summing each of the domain box scores, with scores ranging from 0 to 18, with the higher values representing more severe impairment.
2. Change from baseline to Week 49 on the Mini-Mental State Examination (MMSE)
[ Time Frame: Baseline to Week 49 ]

The Mini Mental State Examination (MMSE) is a brief clinical cognitive examination commonly used to screen for dementia and other cognitive deficits that has a total score of 0-30. Higher scores indicate better cognitive function.
3. Percentage of Participants with Adverse Events
[ Time Frame: Up to approximately 51 months ]

4. Serum concentration of MTAU9937A at specified timepoints
[ Time Frame: Weeks 1, 3, 5, 9, 13, 25, 37, and 49, and at treatment discontinuation (up to week 48) ]

5. Incidence of anti-drug antibodies (ADAs) during the study relative to the prevalence of ADAs at baseline
[ Time Frame: Weeks 1, 13, 25, 37 and 49, and at treatment discontinuation (up to week 48) ]

Open or close this module Eligibility
Minimum Age: 50 Years
Maximum Age: 85 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • National Institute on Aging/Alzheimer's Association core clinical criteria for probable AD dementia
  • Evidence of the AD pathological process, by a positive amyloid assessment either on CSF Aβ1-42 as measured on Elecsys β-Amyloid(1-42) Test System OR amyloid PET scan
  • AD dementia of moderate severity, as defined by a screening MMSE score of 16-21 points, inclusive, and a CDR-GS of 1 or 2
  • Availability of a person with sufficient contact with the participant to be able to provide accurate information on the participant's cognitive, behavioral and functional ability

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Inability to tolerate MRI procedures or contraindication to MRI
  • Contraindication to PET imaging
  • Residence in a skilled nursing facility
  • Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study, or bias the assessment of the clinical or mental status of the participant to a significant degree
  • Any evidence of a condition other than AD that may affect cognition
  • Substance abuse within the past 2 years
  • Use of any experimental therapy within 90 days or 5 half-lives prior to screening, whichever is greater, or any passive immunotherapy against tau
  • Use of any passive immunotherapy (immunoglobulin) against Aβ, unless the last dose was at least 1 year prior to screening or any active immunotherapy (vaccine) that is under evaluation to prevent or postpone cognitive decline
  • Any other biologic therapy or previous treatment with medications specifically intended to treat Parkinsonian symptoms or any other non-AD neurodegenerative disorder within 1 year of screening
  • Systemic immunosuppressive therapy within 12 months of screening through the entire study period
  • Typical antipsychotic or neuroleptic medication within 6 months of screening
  • Daily treatment with any of the following classes of medication (except for intermittent short-term use): opiates or opioids, benzodiazepines, barbiturates, hypnotics, or any medication with clinically significant centrally-acting antihistamine or anticholinergic activity
  • Stimulant medications, unless the dose has been stable within the 6 months prior to screening and is expected to be stable throughout the study
Open or close this module Contacts/Locations
Central Contact Person: Reference Study ID Number: GN40040 www.roche.com/about_roche/roche_worldwide.htm
Telephone: 888-662-6728 (U.S. and Canada)
Email: global-roche-genentech-trials@gene.com
Study Officials: Clinical Trials
Study Director
Hoffmann-La Roche
Locations: United States, Florida
JEM Research LLC
[Recruiting]
Atlantis, Florida, United States, 33462
Brain Matters Research, Inc.
[Recruiting]
Delray Beach, Florida, United States, 33445
Neuropsychiatric Research; Center of Southwest Florida
[Recruiting]
Fort Myers, Florida, United States, 33912
Compass Research East, LLC
[Recruiting]
Orlando, Florida, United States, 32806
United States, Massachusetts
Alzheimers Disease Center
[Recruiting]
Quincy, Massachusetts, United States, 02169
United States, Pennsylvania
Abington Neurological Associates
[Recruiting]
Willow Grove, Pennsylvania, United States, 19090
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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