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11C-L-deprenyl-D2

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment17

FDA Designations

No designations recorded

Clinical trial landscape

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 small molecule being studied for use in healthy volunteers and in patients with Alzheimer's disease. It is a positron emission tomography (PET) tracer, meaning it is designed to be used in imaging to visualize biological processes in the body. The drug is currently in Phase 1 clinical development.

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

11C-L-deprenyl-D2 is being studied for use in Alzheimer's disease as a diagnostic imaging agent. It is intended to be used with PET scans to help visualize or measure certain aspects of the disease. The drug is in Phase 1 clinical trials to evaluate its safety and how it behaves in the body.

Who makes 11C-L-deprenyl-D2?

11C-L-deprenyl-D2 is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY on the OTC market. The company is conducting clinical research to evaluate the drug's potential as a diagnostic tool.

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

11C-L-deprenyl-D2 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and potential uses. The drug is not yet available for clinical use outside of research settings.

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

11C-L-deprenyl-D2 has been studied in one clinical trial, identified as NCT01701089. This Phase 1 study, titled 'A Study of RO4602522 in Patients With Alzheimer Disease and in Healthy Volunteers,' was conducted in Sweden and enrolled 17 participants aged 50 years and older. The trial has been completed.

Is 11C-L-deprenyl-D2 the same as RO4602522?

Yes, 11C-L-deprenyl-D2 is also known as RO4602522. The clinical trial NCT01701089, which studied the drug, used the name RO4602522 in its title. Both names refer to the same investigational compound being developed by Roche.