A Study of RO4602522 in Patients With Alzheimer Disease and in Healthy Volunteers

An Open-Label, Parallel Group Study to Assess the Inhibition of Brain MAO-B by RO4602522 After Repeated Dosing in Patients With Alzheimer's Disease and in Healthy Control Subjects

NCT01701089•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This open-label, multiple dose, parallel group study will assess the monoamine oxidase in the brain by in vivo positron emission tomography (PET) and safety of RO4602522 in patients with Alzheimer disease and in healthy volunteers. Patients and volunteers will receive multiple doses of RO4602522 and up to three injections of C11-L-deprenyl-D2 used in the PET.

Eligibility

Age

50 - 80 years

Sex

ALL

Healthy Volunteers

Yes

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 relevant finding on physical examination at screening and Day -1
•No suspicion of cognitive impairment/early dementia from neuropsychological battery as judged by the investigator
•Able to participate and willing to give informed consent, and comply with the study restrictions.
•Alzheimer Disease (AD) patients:
•Probable Alzheimer's disease, based on the National Institute of Neurological and Communicative
•Disorders and Stroke (NINCDS/ADRDA) and DSM-IV criteria
+2 more criteria

Exclusion Criteria

•Medications taken for symptomatic treatment of AD must be maintained on a stable dosage regimen for at least 1 month before Day 1.
•Able to participate in all scheduled evaluations
•The patient has an appropriate caregiver or community dwelling with caregiver capable of accompanying subject on all visits to the center as judged by the investigator.
•In the opinion of the investigator the patient and caregiver will be compliant and have a high probability of completing the study.
•Signed and dated written informed consent obtained from the patient, co-signed by the patient's closest relatives and legally authorized representative, as required by national law for patients that are incapable of giving informed consent.
•General:
•Any active disease of the gastrointestinal (GI) system, liver, or kidneys that could result in altered absorption, excess accumulation, or impaired metabolism or excretion of drugs, including a history of major upper or middle GI tract surgery or current significant chronic disease of the GI tract
•Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the screening assessment
•History of cancer in the past five years, except for fully treated local basal carcinoma, or fully treated carcinoma in situ of cervix
•Any major illness occurring within 1 month prior to the screening examination or febrile illness within 5 days prior to first dose
+15 more criteria

Locations (1)

Stockholm, Sweden

Key Dates

Start Date

September 1, 2012

Primary Completion Date

May 1, 2013

Completion Date

May 1, 2013

Last Updated

November 2, 2016

Enrollment

ACTUAL participants

Conditions

Healthy Volunteer, Alzheimer's Disease

Interventions

11C-L-deprenyl-D2

DRUG

RO4602522

DRUG

RO4602522

DRUG