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

NCT01701089 | Completed Phase 1

• 1 other identifier: BP28253
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer, Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

RO4602522 Group 1

EXPERIMENTAL

Drug: 11C-L-deprenyl-D2; Drug: RO4602522

RO4602522 Group 2

EXPERIMENTAL

Drug: 11C-L-deprenyl-D2; Drug: RO4602522

Interventions

11C-L-deprenyl-D2 DRUG

Intravenous injection of 11C-L-deprenyl-D2 before positron emission tomography (PET); up to 3 injections in total

RO4602522 Group 1; RO4602522 Group 2

RO4602522 DRUG

Multiple doses of RO4602522 for 14 days

RO4602522 Group 1

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• History of psychotropic medicine abuse
• At risk of suicide in the opinion of the investigator or having a Yes to question number 4 or 5 of the Suicidal Ideation section of the C-SSRS
• Administration of ionizing radiation or radioisotope for research, diagnostics test or therapy within 12 months prior to the present study which would exceed the local yearly radiation dose exposures for participation in research studies (except for dental x-rays, minimal plain films such as chest and ankle X-rays) or subjects who regularly work with ionizing radiation or radioactive material.
• Participation in a clinical study with an investigational drug within 3 months before screening
• Positive test for hepatitis B, hepatitis C, or HIV at screening

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Stockholm, 141 86, Sweden

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

sembragiline

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2012
• First Posted: October 4, 2012
• Study Start: September 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

SE (1)