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11C-L-deprenyl-D2

Phase 1

Alzheimer's Disease | Small molecule | Neurology |Roche Holding AG|Trials Updated: Nov 2, 2016

11C-L-deprenyl-D2 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2012

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment17

FDA Designations

No designations recorded

11C-L-deprenyl-D2 clinical trials

11C-L-deprenyl-D2 · 1 trial · 1 indication

Phase 1 1
NCT01701089A Study of RO4602522 in Patients With Alzheimer Disease and in Healthy VolunteersHealthy Volunteer, Alzheimer's Disease
COMPLETED17 Analytics
PHASE1COMPLETED
A Study of RO4602522 in Patients With Alzheimer Disease and in Healthy Volunteers
Healthy Volunteer, Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in monoamine oxidase (MAO-B) enzyme activity as measured by in vivo positron emission tomography (PET)
Days 1, 14, and between days 15 and 34
Pharmacokinetics: Plasma concentration of RO4602522
Days 1, 8, 14, and between Days 15 and 34

Secondary Endpoints

Reduction of 11C-L-deprenyl-D2 tracer uptake by in vivo positron emission tomography (PET)
Days 1, 14, and between days 15 and 34
Safety: incidence of adverse events
35 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RO4602522 Group 1EXPERIMENTAL -
RO4602522 Group 2EXPERIMENTAL -

Interventions

NameTypeDescription
11C-L-deprenyl-D2DRUGIntravenous injection of 11C-L-deprenyl-D2 before positron emission tomography (PET); up to 3 injections in total
RO4602522DRUGMultiple doses of RO4602522 for 14 days
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Eligibility Criteria

Age Range50 Years to 80 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: General: * Adults between 50-80 years of age. Females must be of non-child-bearing potential or if of child-bearing potential must use an acceptable form of contraception * Body mass index (BMI) 18.0-32.0 kg/m2 inclusive Healthy volunteers: * Healthy, with no clinically relev...

Countries:Sweden
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Frequently asked questions about 11C-L-deprenyl-D2

What is 11C-L-deprenyl-D2?

11C-L-deprenyl-D2 is an investigational positron emission tomography imaging agent being studied in Alzheimer's disease. It is a small molecule developed by Roche Holding AG under the ticker RHHBY. It is designed for use as a research imaging tool rather than as a therapeutic treatment, and it remains in Phase 1 clinical development.

What is 11C-L-deprenyl-D2 used for in Alzheimer's disease?

11C-L-deprenyl-D2 is used as a PET imaging agent in Alzheimer's disease research. Roche studied it in patients with Alzheimer's disease and in healthy volunteers to evaluate its behavior as an imaging tracer. It is not a treatment for Alzheimer's disease and is not approved for clinical use.

Who makes 11C-L-deprenyl-D2?

11C-L-deprenyl-D2 is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the clinical study of the compound, registered as NCT01701089, titled A Study of RO4602522 in Patients With Alzheimer Disease and in Healthy Volunteers.

What phase is 11C-L-deprenyl-D2 in?

11C-L-deprenyl-D2 is in Phase 1 development. It is investigational and has not been approved by the FDA. Roche has completed one Phase 1 trial of the compound, and no active trials are currently listed for it.

What clinical trials is 11C-L-deprenyl-D2 in?

11C-L-deprenyl-D2 has been studied in one completed Phase 1 trial, NCT01701089, titled A Study of RO4602522 in Patients With Alzheimer Disease and in Healthy Volunteers. The trial enrolled 17 participants in Sweden, included healthy volunteers, and used a controlled design without randomization or double blinding.