[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

888-662-6728 (U.S. and Canada)

Email address

global-roche-genentech-trials@gene.com

Condition

Alzheimer's Disease

Treatment type

Interventional

Investigational product

MTAU9937A

Phase

Phase 2

Sponsor

Genentech, Inc.

ClinicalTrials.gov identifier

NCT03828747

Study number

GN40040

Understanding clinical trials

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About the study

This Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the clinical efficacy, safety, pharmacokinetics, and pharmacodynamics of semorinemab 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. There may be up to three study cohorts.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. National Institute on Aging/Alzheimer's Association core clinical criteria for probable AD dementia
  2. 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
  3. 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
  4. 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
  1. Pregnant or breastfeeding
  2. Inability to tolerate MRI procedures or contraindication to MRI
  3. Contraindication to PET imaging
  4. Residence in a skilled nursing facility
  5. 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
  6. Any evidence of a condition other than AD that may affect cognition
  7. Substance abuse within the past 2 years
  8. Use of any experimental therapy within 90 days or 5 half-lives prior to screening, whichever is greater, or any passive immunotherapy against tau
  9. 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
  10. 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
  11. Systemic immunosuppressive therapy within 12 months of screening through the entire study period
  12. Typical antipsychotic or neuroleptic medication within 6 months of screening
  13. 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
  14. Stimulant medications, unless the dose has been stable within the 6 months prior to screening and is expected to be stable throughout the study

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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