A Study of Gantenerumab in Participants With Prodromal Alzheimer's Disease | NCT01224106 | Trialant

A Study of Gantenerumab in Participants With Prodromal Alzheimer's Disease | NCT01224106 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Adult participants, 50-85 years of age

Participants with prodromal Alzheimer's disease who are not receiving memantine or cholinesterase inhibitors

Has a study partner who in the investigator's judgement has frequent and sufficient contact with the participant as to be able to provide accurate information as to the participant'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 participant's memory (over the last 12 months), which the participant may or may not be aware of

Screening Mini Mental State Exam (MMSE) score of 24 or above

Additional inclusion criteria for sub study:

Able and willing to travel to PET imaging center and complete the planned scanning sessions

Past and planned exposure to ionizing radiation not exceeding safe and permissible levels

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 (myocardial infarction, angina pectoris)

Additional exclusion criteria for sub study:

Inclusion in a research and/or medical protocol involving PET ligands or other radioactive agents within 12 months

Present or planned participation in a research and/or medical protocol involving PET ligands or radioactive agents other than study WN25203

Have planned or are planning to have exposure to ionizing radiation that in combination with the planned administration with study amyloid PET ligand would result in a cumulative exposure that exceeds local recommended exposure limits