Healthy Volunteer, Alzheimer's Disease
Conditions
Brief 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.
Interventions
DRUG11C-L-deprenyl-D2
Intravenous injection of 11C-L-deprenyl-D2 before positron emission tomography (PET); up to 3 injections in total
DRUGRO4602522
Multiple doses of RO4602522 for 14 days
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
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 * Have a MMSE score at screening between 17 and 26 inclusive * Modified Hachinski Ischemia Scale score of \</=4 * A neuroimaging evaluation of the brain by MRI which supports a diagnosis of AD, with no evidence of focal disease to account for dementia or MRI
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Sweden
Outcome results
None listed