A Study to Evaluate the Efficacy and Safety of RO7105705 in Patients with Moderate Alzheimer’s disease

Phase 1

Active, not recruiting

• Conditions: Alzheimer’s disease (AD); MedDRA version: 20.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-003398-87-ES
• Lead Sponsor: Roche Farma, S.A por delegación de Genentech, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-31
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 260

Inclusion Criteria

- Age between 50 and 85 years
- National Institute on Aging/Alzheimer’s Association core clinical criteria for probable AD dementia
- Evidence of the AD pathological process, by a positive amyloid assessment either on cerebrospinal fluid Aß 1- 42 or amyloid positron emission tomography (PET) scan. Historical amyloid PET scans may be accepted in some cases.
- AD dementia of moderate severity, as defined by a screening MMSE score of 16-21 points and a Clinical Dementia Rating (CDR)-Global Score of 1 or 2
- Availability of a person with sufficient contact with the patient to be able to provide accurate information regarding the participant’s cognitive, behavioral, and functional abilities
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 240

Exclusion Criteria

- Pregnant or breastfeeding
- Inability to tolerate MRI procedures or contraindication to MRI
- Contraindication to PET imaging
- Residence in a skilled nursing facility
- Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator’s judgment, precludes the patient’s safe participation in and completion of the study, or bias the assessment of the clinical or mental status of the participant to a significant degree
- Any evidence of a condition other than AD that may affect cognition
- Substance abuse within the past 2 years
- Use of any experimental therapy within 90 days or 5 half-lives prior to screening, whichever is greater, or any passive immunotherapy against tau
- Use of any passive immunotherapy (immunoglobulin) against Aß, unless the last dose was at least 1 year prior to screening or any active immunotherapy (vaccine) that is under evaluation to prevent or postpone cognitive decline
- Any other biologic therapy or previous treatment with medications specifically intended to treat Parkinsonian symptoms or any other non-AD neurodegenerative disorder within 1 year of screening
- Systemic immunosuppressive therapy within 12 months of screening through the entire study period
- Typical antipsychotic or neuroleptic medication within 6 months of screening
- Daily treatment with any of the following classes of medication (except for intermittent short-term use): opiates or opioids, benzodiazepines, barbiturates, hypnotics, or any medication with clinically significant centrally-acting antihistamine or anticholinergic activity
- Stimulant medications, unless the dose has been stable within the 6 months prior to screening and is
expected to be stable throughout the study

Study & Design

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