A Study of Gantenerumab in Patients With Prodromal Alzheimer's Disease

Phase 1

• Conditions: Prodromal Alzheimer’s Disease; MedDRA version: 17.0Level: LLTClassification code 10066571Term: Progression of Alzheimer's diseaseSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2010-019895-66-DE
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-29
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 797

Inclusion Criteria

- Adult patients, 50-85 years of age
- Patients with prodromal Alzheimer's Disease who are not receiving
memantine or cholinesterase inhibitors
- Has a study partner who is able to provide accurate information as to
the patient's cognitive and functional abilities, who agrees to provide
information at clinic visits which require partner input for scale
completion
- Has had sufficient education or work experience to exclude mental
retardation
- Study partner has noticed a recent gradual decrease in patient's
memory (e.g. over the last 12 months), which the patient may or may
not be aware of
- Screening MMSE score of 24 or above

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 154
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 616

Exclusion Criteria

- Other prior or current neurologic or medical disorder which may
currently or during the course of the study impair cognition or
psychiatric functioning
- A history of stroke
- A documented history of transient ischemic attack within the last 12
months
- History of schizophrenia, schizoaffective or bipolar disorder
- Currently meets criteria for major depression
- Within the last 2 years, unstable or clinical significant cardiovascular
disease (e.g. myocardial infarction, angina pectoris)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified