Autosomal Dominant Alzheimers DiseasePhase 2/3NCT06996730
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
A Phase 2/3 study testing Donanemab and RG6289 in people with Autosomal Dominant Alzheimers Disease and Early Onset Alzheimer Disease, run by Banner Health at 1 site in Colombia.
Trial summary
The study will be conducted in 2 blinded parts (Part 1 and Part 2). In Part 1, study participants who are mutation carriers will receive active donanemab and non-mutation carriers will receive placebo-donanemab for up to 18 months (76 weeks), with a minimum treatment period of 9 months. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Autosomal Dominant Alzheimers Disease, Early Onset Alzheimer Disease, Alzheimers Disease
- What is being tested?
- Donanemab and RG6289
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteColombia
- Study dates
- 8 Jul 2026to 1 Jun 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Membership in PSEN1 E280A mutation carrier kindred.
- Agrees to conditions of, and is willing to undergo, genetic testing (e.g., APOE, PSEN1 E280A, and other genetic testing allowed by local regulatory requirements).
- 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. b. Or determined to have MCI with amnestic presentation as defined by:
- 1. Cognitive concern in the judgment of the Investigator, based in part on the: i. CERAD Word List: Recall <3 for participants with less than 9 years of education. ii. CERAD Word List: Recall <5 for participants with 9 or more years of education. iii. Preservation of independence in functional activities in the judgment of the Investigator. c. Or determined to have mild AD dementia as defined by:
- Meets the 2011 National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria for probable AD, and
- Has a CDR-GS of 0.5 or 1, with the memory box score ≥0.5.
Who cannot join
- 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 (persistent neurological deficit or structural brain damage) CNS trauma (e.g., cerebral contusion).
- 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 (DSM-5-TR) or symptom (e.g., hallucinations, agitation, paranoia) that could affect the participant's ability to complete evaluations.
- History of seizures (excluding febrile seizures of childhood, or other isolated seizure episodes that were not due to epilepsy in the judgment of the Investigator, and required at most time-limited anticonvulsant treatment, and which occurred more than 7 years prior to the screening visit).
- Women who are pregnant or intend to become pregnant during the conduct of this study.
Show all 19Show fewer
- Women who are nursing infants or intend to nurse infants during the conduct of this study.
- Known (or prior) hypersensitivity to donanemab, RG6289, or any excipients of RG6289.
- History of or active inflammatory bowel disease (e.g., Crohn disease or ulcerative colitis).
- Medical history of malignancy in the past 5 years, with the following exceptions:
- If considered to be cured or,
- If not being actively treated with anti-cancer therapy or radiotherapy and, in the opinion of the Investigator, is not likely to require treatment in the ensuing 5 years and,
- 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, in the opinion of the Investigator, may compromise eligibility to the study. The Medical Monitor is available to the Investigator to advise and answer any questions.
- Inability to tolerate MRI procedures or contraindication to MRI, including, but not limited to, presence of pacemakers not compatible with MRI, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin, or body that would contraindicate an MRI scan, or any other clinical history or examination finding that, in the judgment of the Investigator, would pose a potential hazard in combination with 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, including anti-amyloid small molecules (i.e., BACEi and GSIs, other GSMs) within five half-lives or 16 weeks prior to screening (calculated from the last safety follow-up visit of the previous study), whichever is longer. Note: The participant may be eligible for this study if it can be documented that he/she was randomized to placebo
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
Neurosciences Group of Antioquia, University of Antioquia
Medellín, Antioquia
David F Aguillon Nino, M.D., +57 604 219 2385, david.aguillon@gna.org.co
David F Aguillon Nino, M.D.
About this study
Official title: A Double-Blind, Placebo-Controlled, Double-Dummy Study of Donanemab and RG6289 in PSEN1 E280A Mutation Carriers, and in Non-Randomized, Placebo-Treated Non-Carriers From the Same Kindred, to Evaluate the Efficacy and Safety of Donanemab, RG6289, or the Combination of Donanemab and RG6289, in the Treatment of Autosomal-Dominant Alzheimer's Disease
The study will be conducted in 2 blinded parts (Part 1 and Part 2). In Part 1, study participants who are mutation carriers will receive active donanemab and non-mutation carriers will receive placebo-donanemab for up to 18 months (76 weeks), with a minimum treatment period of 9 months. Amyloid PET scans will be conducted at screening, 9, and 18 months in Part 1. Participants who are at or below 11 CL at screening or reach complete amyloid plaque clearance as measured by florbetapir F18 PET (defined as ≤11 CL) at 9 months will initiate Part 2. Participants who are ≤11 CL at screening may delay their entry into Part 2 for up to 6 months at the discretion of the Investigator. All remaining participants will start Part 2 after completing 18 months (76 weeks) in Part 1 independent of amyloid results. Non-carriers will receive placebo in both Parts 1 and 2.
In Part 2, study participants who are mutation carriers will be randomized 1:1:1:1 in a full factorial design to receive either RG6289 + placebo-donanemab (RG6289 alone group), donanemab + placebo-RG6289 (donanemab alone group), the combination of RG6289 and donanemab (combination group), or placebo-RG6289 and placebo-donanemab (placebo group). All non-carriers will be assigned to the placebo group. CDR-GS at the end of Part 1 and the amyloid level using the last completed amyloid PET scan in Part 1 will be used for stratification. All study participants will participate in a double-dummy design for the duration of Part 2 receiving both an intravenous (IV) infusion at the required interval for the donanemab or matching placebo as well as a daily oral treatment of RG6289 or matching placebo.
An exploratory outcome of Part 1 is a comparison of the amyloid clearance between this ADAD cohort and historical controls using propensity score matching. The primary outcome in Part 2 is change from the start of Part 2 through the end of Part 2 in brain amyloid load in PSEN1 E280A mutation carriers as measured by amyloid PET imaging. Other endpoints will include fluid and imaging biomarkers and measures of cognition and functioning. The maximum study duration for any individual participant will be 3 years, not including the screening or follow-up periods
- Being tested
- Donanemab, RG6289, Donanemab placebo, RG6289 placebo
- Keywords
- Dementia
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonanemabDrug
IV Infusion
RG6289Drug
Oral tablet
Donanemab placeboDrug
IV placebo
RG6289 placeboDrug
Oral tablet placebo
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Donanemab | Experimental | Donanemab will be administered per the schedule specified in the treatment arm for all PSEN1 E280A Carriers Receives: Drug: Donanemab |
| Part 1: Donanemab placebo | Placebo comparator | Donanemab placebo will be administered per the schedule specified in the treatment arm for all PSEN1 E280A Non-Carriers Receives: Drug: Donanemab placebo |
| Part 2: Donanemab + RG6289 placebo | Experimental | Donanemab plus RG6289 placebo will be administered per the schedule specified in the treatment arm for all PSEN1 E280A Carriers Receives: Drug: Donanemab; Drug: RG6289 placebo |
| Part 2: RG6289 + Donanemab placebo | Experimental | RG6289 plus donanemab placebo will be administered per the schedule specified in the treatment arm for all PSEN1 E280A Carriers Receives: Drug: RG6289; Drug: Donanemab placebo |
| Part 2: RG6289 plus donanemab | Experimental | RG6289 plus donanemab will be administered per the schedule specified in the treatment arm for all PSEN1 E280A Carriers Receives: Drug: Donanemab; Drug: RG6289 |
| Part 2: RG6289 placebo plus donanemab placebo | Placebo comparator | RG6289 placebo plus donanemab placebo will be administered per the schedule specified in the treatment arm for all assigned PSEN1 E280A Carriers and all PSEN1 E280A Non-Carriers Receives: Drug: Donanemab placebo; Drug: RG6289 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Change in amyloid load as measured by centiloid (CL) [F18]Florbetapir-PET as biomarker endpoint
Evaluate the efficacy and safety of donanemab on change in amyloid load as measured by centiloid (CL) [F18] Florbetapir-PET in presenilin 1 (PSEN1) E280A mutation carriers (Part 1). CL calculated using [f18] Florbetapir PET non-partial volume corrected (regional spread function) standardized uptake value ratio cortical composite (F18 Florbetapir PET SUVR).
Measured: Part 1: Screening, Month 9, and Month 18
Part 2: Maintenance of Low Levels of Brain Amyloid as Measured by centiloid (Cl) [F18]Florbetapir-PET Following Combined Intervention of Donanemab and RG6289
Evaluate the individual and relative efficacy and safety, as well as potential synergy, of donanemab, RG6289, and the combination of RG6289 with donanemab, to achieve and/or maintain low levels of brain amyloid as measured by centiloid (CL) [F18] Florbetapir-PET in asymptomatic and symptomatic PSEN1 E280A mutation carriers. CL calculated using [F18] Florbetapir-PET non-partial volume corrected (regional spread function) standardized uptake value ratio cortical composite (F18 Florbetapir-PET SUVR)
Measured: Duration of Part 2 Participation (up to 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start8 Jul 2026
- Primary completion1 Jun 2030 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autosomal Dominant Alzheimers DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Banner Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Universidad de Antioquia
- Responsible party
- Sponsor
- Investigators
- Robert Alexander, M.D., Principal investigator, Banner Alzheimer's InstituteJessica Langbaum, Ph.D., Principal investigator, Banner Alzheimer's InstituteEric Reiman, M.D., Principal investigator, Banner Alzheimer's InstituteYakeel T. Quiroz-Gaviria, Ph.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996730
- Sponsor's protocol ID
- API-2
- Other IDs
- 1R01AG086363-01
- Status last verified
- Aug 2026
- First submitted
- 29 Apr 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Double-Dummy Study of Donanemab and RG6289 in PSEN1 E280A Mutation Carriers, and in Non-Randomized, Placebo-Treated Non-Carriers From the Same Kindred, to Evaluate the Efficacy and Safety of Donanemab, RG6289, or the Combination of Donanemab and RG6289, in the Treatment of Autosomal-Dominant Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06996730
- Acronym / sponsor ID
- API-2
- Keywords
- Dementia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Banner HealthUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Universidad de Antioquia
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will be conducted in 2 blinded parts (Part 1 and Part 2). In Part 1, study participants who are mutation carriers will receive active donanemab and non-mutation carriers will receive placebo-donanemab for up to 18 months (76 weeks), with a minimum treatment period of 9 months. Amyloid PET scans will be conducted at screening, 9, and 18 months in Part 1. Participants who are at or below 11 CL at screening or reach complete amyloid plaque clearance as measured by florbetapir F18 PET (defined as ≤11 CL) at 9 months will initiate Part 2. Participants who are ≤11 CL at screening may delay their entry into Part 2 for up to 6 months at the discretion of the Investigator. All remaining participants will start Part 2 after completing 18 months (76 weeks) in Part 1 independent of amyloid results. Non-carriers will receive placebo in both Parts 1 and 2.
In Part 2, study participants who are mutation carriers will be randomized 1:1:1:1 in a full factorial design to receive either RG6289 + placebo-donanemab (RG6289 alone group), donanemab + placebo-RG6289 (donanemab alone group), the combination of RG6289 and donanemab (combination group), or placebo-RG6289 and placebo-donanemab (placebo group). All non-carriers will be assigned to the placebo group. CDR-GS at the end of Part 1 and the amyloid level using the last completed amyloid PET scan in Part 1 will be used for stratification. All study participants will participate in a double-dummy design for the duration of Part 2 receiving both an intravenous (IV) infusion at the required interval for the donanemab or matching placebo as well as a daily oral treatment of RG6289 or matching placebo.
An exploratory outcome of Part 1 is a comparison of the amyloid clearance between this ADAD cohort and historical controls using propensity score matching. The primary outcome in Part 2 is change from the start of Part 2 through the end of Part 2 in brain amyloid load in PSEN1 E280A mutation carriers as measured by amyloid PET imaging. Other endpoints will include fluid and imaging biomarkers and measures of cognition and functioning. The maximum study duration for any individual participant will be 3 years, not including the screening or follow-up periods
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1: Donanemab | Experimental | Drug: DonanemabDonanemab will be administered per the schedule specified in the treatment arm for all PSEN1 E280A Carriers |
| Part 1: Donanemab placebo | Placebo comparator | Drug: Donanemab placeboDonanemab placebo will be administered per the schedule specified in the treatment arm for all PSEN1 E280A Non-Carriers |
| Part 2: Donanemab + RG6289 placebo | Experimental | Drug: Donanemab, Drug: RG6289 placeboDonanemab plus RG6289 placebo will be administered per the schedule specified in the treatment arm for all PSEN1 E280A Carriers |
| Part 2: RG6289 + Donanemab placebo | Experimental | Drug: RG6289, Drug: Donanemab placeboRG6289 plus donanemab placebo will be administered per the schedule specified in the treatment arm for all PSEN1 E280A Carriers |
| Part 2: RG6289 plus donanemab | Experimental | Drug: Donanemab, Drug: RG6289RG6289 plus donanemab will be administered per the schedule specified in the treatment arm for all PSEN1 E280A Carriers |
| Part 2: RG6289 placebo plus donanemab placebo | Placebo comparator | Drug: Donanemab placebo, Drug: RG6289 placeboRG6289 placebo plus donanemab placebo will be administered per the schedule specified in the treatment arm for all assigned PSEN1 E280A Carriers and all PSEN1 E280A Non-Carriers |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Membership in PSEN1 E280A mutation carrier kindred.
- Agrees to conditions of, and is willing to undergo, genetic testing (e.g., APOE, PSEN1 E280A, and other genetic testing allowed by local regulatory requirements).
- Males and females aged 25-65 inclusive.
- Must meet one of the following criteria:
- 1. Cognitive concern in the judgment of the Investigator, based in part on the: i. CERAD Word List: Recall <3 for participants with less than 9 years of education. ii. CERAD Word List: Recall <5 for participants with 9 or more years of education. iii. Preservation of independence in functional activities in the judgment of the Investigator. c. Or determined to have mild AD dementia as defined by:
Key exclusion criteria (19 listed)
- 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 (persistent neurological deficit or structural brain damage) CNS trauma (e.g., cerebral contusion).
- 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 (DSM-5-TR) or symptom (e.g., hallucinations, agitation, paranoia) that could affect the participant's ability to complete evaluations.
- History of seizures (excluding febrile seizures of childhood, or other isolated seizure episodes that were not due to epilepsy in the judgment of the Investigator, and required at most time-limited anticonvulsant treatment, and which occurred more than 7 years prior to the screening visit).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DonanemabIV Infusion | Drug | Part 1: Donanemab, Part 2: Donanemab + RG6289 placebo, Part 2: RG6289 plus donanemab |
| RG6289Oral tablet | Drug | Part 2: RG6289 + Donanemab placebo, Part 2: RG6289 plus donanemab |
| Donanemab placeboIV placebo | Drug | Part 1: Donanemab placebo, Part 2: RG6289 + Donanemab placebo, Part 2: RG6289 placebo plus donanemab placebo |
| RG6289 placeboOral tablet placebo | Drug | Part 2: Donanemab + RG6289 placebo, Part 2: RG6289 placebo plus donanemab placebo |
Primary outcome
Part 1: Change in amyloid load as measured by centiloid (CL) [F18]Florbetapir-PET as biomarker endpoint
Time frame: Part 1: Screening, Month 9, and Month 18
Evaluate the efficacy and safety of donanemab on change in amyloid load as measured by centiloid (CL) [F18] Florbetapir-PET in presenilin 1 (PSEN1) E280A mutation carriers (Part 1). CL calculated using [f18] Florbetapir PET non-partial volume corrected (regional spread function) standardized uptake value ratio cortical composite (F18 Florbetapir PET SUVR).
Part 2: Maintenance of Low Levels of Brain Amyloid as Measured by centiloid (Cl) [F18]Florbetapir-PET Following Combined Intervention of Donanemab and RG6289
Time frame: Duration of Part 2 Participation (up to 18 months)
Evaluate the individual and relative efficacy and safety, as well as potential synergy, of donanemab, RG6289, and the combination of RG6289 with donanemab, to achieve and/or maintain low levels of brain amyloid as measured by centiloid (CL) [F18] Florbetapir-PET in asymptomatic and symptomatic PSEN1 E280A mutation carriers. CL calculated using [F18] Florbetapir-PET non-partial volume corrected (regional spread function) standardized uptake value ratio cortical composite (F18 Florbetapir-PET SUVR)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Alexander, M.D. principal investigator
Banner Alzheimer's Institute
Jessica Langbaum, Ph.D. principal investigator
Banner Alzheimer's Institute
Eric Reiman, M.D. principal investigator
Banner Alzheimer's Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Donanemab and RG6289 in people with Autosomal Dominant Alzheimers Disease and Early Onset Alzheimer Disease, run by Banner Health at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Gordon, M.S. ((602) 839 - 6020, David.Gordon@bannerhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Change in amyloid load as measured by centiloid (CL) [F18]Florbetapir-PET as biomarker endpoint (time frame: Part 1: Screening, Month 9, and Month 18). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.