A Multiple Ascending Dose Study of R1450 in Patients With Alzheimer Disease.

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00531804
• Collaborator: (none)
• Enrollment: 60
• Locations: 9
• Arm: 1
• Duration (Months): 45
• Patients Per Site: 6.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of R1450 in patients with mild to moderate Alzheimer Disease. Patients will be randomized to receive either R1450 or placebo by intravenous infusion for a total of 7 doses. The starting dose will be escalated in subsequent cohorts of patients in an adaptive manner, after a satisfactory assessment of safety, tolerability and pharmacokinetics of the previous dose. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease	Drug: gantenerumab	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multi-center, Multiple-ascending Dose, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO4909832 Following Intravenous Infusion in AD Patients
• Study Start Date: Dec 1, 2006
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: gantenerumab; Administered iv at escalating doses (7 cohorts)

Outcome Measures

Primary Outcome Measures

1. AEs, laboratory parameters, vital signs. [Throughout study]

2. Pharmacokinetic parameters of R1450 in plasma [Throughout study]

Secondary Outcome Measures

1. CSF biomarkers, clinical efficacy parameters. [Throughout study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• adult patients, 50-90 years of age;

• diagnosis of probable Alzheimer Disease, with symptoms >=1 year prior to screening;

• meets DSM-IV criteria for Alzheimer-type dementia;

• stabilised on approved medications for treatment of Alzheimer Disease for >=4 months prior to baseline.

Exclusion Criteria:

• active major depressive disorder, or a history of bipolar disorder;

• history of schizophrenia;

• concurrent participation in a non-pharmacological trial with a key objective of improving cognition;

• prior randomisation in any R1450 trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		København		Denmark	2100
2		Ramat Gan		Israel	52621
3		Amsterdam		Netherlands	1081 GM
4		Malmoe		Sweden	20502
5		Stockholm		Sweden	14186
6		Blackpool		United Kingdom	FY20JH
7		Glasgow		United Kingdom	G20 0XA
8		Southampton		United Kingdom	SO30 3JB
9		Swindon		United Kingdom	SN3 6BW

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT00531804
• Other Study ID Numbers: NN19866
• First Posted: Sep 19, 2007
• Last Update Posted: Nov 2, 2016
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Alzheimer Disease

Study Results

No Results Posted as of Nov 2, 2016