A Study to Evaluate Efficacy and Safety of RO7105705 in Patients with Prodromal to Mild Alzheimer's disease

Phase 1

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

• Registration Number: EUCTR2017-001800-31-FR
• Lead Sponsor: Genentech Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-06
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

- Age between 50 and 80 years
- National Institute on Aging/Alzheimer’s Association core clinical criteria for probable AD dementia or mild cognitive impairment (prodromal AD)
- Evidence of the AD pathological process, by a positive amyloid assessment either on cerebrospinal fluid Aß1-42 OR amyloid positron emission tomography (PET) scan. Historical amyloid PET scans may be accepted in some cases
- Mild AD symptomatology, as defined by a screening Mini-Mental State Examination score of >= 20 points and Clinical Dementia Rating (CDR) - Global Score of 0.5 or 1
- Abnormal memory function at screening
- Availability of a person with sufficient contact with the patient to be able to provide accurate information on the patient’s cognitive and functional ability
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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 280

Exclusion Criteria

- Pregnant or breastfeeding
- Inability to tolerate magnetic resonance imaging (MRI) procedures or contraindication to MRI
- Able to undergo either PET imaging or lumbar dural puncture, or both, and patients with contraindications to both procedures are ineligible
- Residence in a skilled nursing facility
- Any serious medical condition or abnormality in clinical laboratory tests that remains abnormal on retest and, 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
- Alcohol or 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 and any passive immunotherapy (immunoglobulin) against tau, except use of RO7105705 in Genentech Study GN39058, as long as the last dose was at least 90 days prior to screening
- Use of any passive immunotherapy (immunoglobulin) against Aß, unless the last dose was at least 1 year prior to screening and any active immunotherapy (vaccine) that is under evaluation to prevent or postpone cognitive decline
- Any previous treatment with medications specifically intended to treat Parkinsonian symptoms or any other 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, which is permitted except within 2 days or 5 half-lives (whichever is longer) prior to any COA such as atypical antipsychotics, Opiates or opioids ,Benzodiazepines, barbiturates, or hyponotics and any medication with 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