Last updated 35 days ago

A Study of Donanemab, RG6289, or the Combination of Donanemab and RG6289 in Presenilin 1 (PSEN1) E280A Mutation Carriers for the Treatment of Autosomal-Dominant Alzheimer's Disease

240 patients around the world

Available in Colombia

Banner Health

240Patients around the world

This study is for people with

Alzheimer disease

Requirements for the patient

To 65 Years

All Gender

Medical requirements

: Membership in PSEN1 E280A mutation carrier kindred.
Agrees to conditions of, and is willing to undergo, genetic testing.
Males and females aged 25-65 inclusive.
Must meet one of the following criteria.
Determined to be cognitively normal as defined by an MMSE of ≥24 for participants with less than 9 years of education or MMSE of ≥26 for participants with 9 or more years of education.
Determined to have MCI with amnestic presentation as defined by cognitive concern in the judgment of the Investigator.
Cognitive concern in the judgment of the Investigator, based in part on the CERAD Word List: Recall <3 for participants with less than 9 years of education.
Cognitive concern in the judgment of the Investigator, based in part on the CERAD Word List: Recall <5 for participants with 9 or more years of education.
Cognitive concern in the judgment of the Investigator, based in part on preservation of independence in functional activities.
Determined to have mild AD dementia as defined by meeting the 2011 National Institute on Aging and the Alzheimer's Association criteria for probable AD.
Has a CDR-GS of 0.5 or 1, with the memory box score ≥0.5.

: Significant medical, psychiatric, or other neurological condition or disorder documented by history, physical, neurological, laboratory examinations that would place the participant at undue risk in the Investigator's judgment or impact the interpretation of efficacy.
History of stroke.
History of severe, clinically significant CNS trauma.
Current presence of bipolar disorder or other clinically significant major psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision.
History of seizures excluding febrile seizures of childhood or other isolated seizure episodes that were not due to epilepsy.
Women who are pregnant or intend to become pregnant during the conduct of this study.
Women who are nursing infants or intend to nurse infants during the conduct of this study.
Known hypersensitivity to donanemab, RG6289, or any excipients of RG6289.
History of or active inflammatory bowel disease.
Medical history of malignancy in the past 5 years, with specific exceptions.
If considered to be cured.
If not being actively treated with anti-cancer therapy or radiotherapy.
For prostate cancer or basal cell carcinoma, no significant progression over the previous 2 years.
In-situ cervix carcinoma that has been successfully treated.
Fully excised non-melanoma skin cancers or in-situ melanoma.
Any surgery or hospitalization during the 4 weeks prior to screening or pre-planned/scheduled during the study period that may compromise eligibility.
Inability to tolerate MRI procedures or contraindication to MRI.
Prior participation in an anti-amyloid therapy trial is allowed if it has been at least 1 year since the last study dose.
Any other investigational treatment within five half-lives or 16 weeks prior to screening.

SponsorBanner Health

Study typeInterventional

Conditions

Alzheimer disease

Requirements

To 65 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06996730