The Alzheimer’s Prevention Initiative Generation Program: study design of two randomized controlled trials for individuals at risk for clinical onset of Alzheimer’s disease
Open accessAbstract
INTRODUCTION: Alzheimer's disease (AD) pathology, including the accumulation of amyloid beta (Aβ) species and tau pathology, begins decades before the onset of cognitive impairment. This long preclinical period provides an opportunity for clinical trials designed to prevent or delay the onset of cognitive impairment due to AD. Under the umbrella of the Alzheimer's Prevention Initiative Generation Program, therapies targeting Aβ, including CNP520 (umibecestat), a β-site-amyloid precursor protein cleaving enzyme-1 (BACE-1) inhibitor, and CAD106, an active Aβ immunotherapy, are in clinical development in preclinical AD. METHODS: ε2/ε4 or ε3/ε4), elevated brain amyloid. Approximately, 3500 individuals will be enrolled in either Generation Study 1 (randomized to cohort 1 [CAD106 injection or placebo, 5:3] or cohort 2 [oral umibecestat 50 mg or placebo, 3:2]) or Generation Study 2 (randomized to oral umibecestat 50 mg and 15 mg, or placebo [2:1:2]). Participants receive treatment for at least 60 months and up to a maximum of 96 months. Primary outcomes include time to event, with event defined as diagnosis of mild cognitive impairment due to AD and/or dementia due to AD, and the Alzheimer's Prevention Initiative preclinical composite cognitive test battery. Secondary endpoints include the Clinical Dementia Rating Sum of Boxes, Repeatable Battery for the Assessment of Neuropsychological Status total score, Everyday Cognition Scale, biomarkers, and brain imaging. DISCUSSION: The Generation Program is designed to assess the efficacy, safety, and biomarker effects of the two treatments in individuals at high risk for AD. It may also provide a plausible test of the amyloid hypothesis and further accelerate the evaluation of AD prevention therapies.
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CAD106 is being used in the API Generation trial of APOE ε4 homozygotes.
“Crenezumab is being used in the API ADAD Colombia trial of known mutation carriers (Tariot et al., 2018), whereas active immunization with CAD106 is being used in the API Generation trial of APOE ε4 homozygotes (Lopez Lopez et al., 2019).”
From Alzheimer Disease: An Update on Pathobiology and Treatment Strategies (2019) · cites this paper as Lopez Lopez et al., 2019
CNP520 was incorporated into one arm of the phase 2/3 API Generation study for secondary prevention in older APOE ε4/ε4 homozygotes.
“This inhibitor was then incorporated into one arm of the phase 2/3 API Generation study (along with CAD106; see above) for secondary prevention of AD in older APOE ε4/ε4 homozygotes (Lopez Lopez et al., 2019).”
From Alzheimer Disease: An Update on Pathobiology and Treatment Strategies (2019) · cites this paper as Lopez Lopez et al., 2019
γ-secretase inhibitors are no longer regarded as a suitable target for the treatment of Alzheimer's disease due to major safety concerns.
“γ secretase inhibitors are no longer regarded a suitable target for the treatment of AD due to major safety concerns (Lopez et al., 2019).”
From An update on the novel and approved drugs for Alzheimer disease (2022) · cites this paper as Lopez et al., 2019
ABvac40 is being assessed as the first active vaccine; in a phase 1 trial in Alzheimer's disease patients aged 50 to 85 years, there was no evidence of incident vasogenic edema or microhemorrhages, and antibodies specific to Aβ40 were generated in 92% who had ABvac40 injections.
“ABvac40 is being assessed as the first active vaccine. AD Patients with aged 50 to 85 years old participated in a phase one trial. There was no evidence of incident vasogenic edema or microhemorrhages. Antibodies specific to Aβ40 were generated in 92 % who had ABvac40 injections (Lopez et al., 2019).”
From An update on the novel and approved drugs for Alzheimer disease (2022) · cites this paper as Lopez et al., 2019
Umibecestat is studied in asymptomatic individuals at risk of developing Alzheimer disease (APOE4 homozygotes or APOE4 heterozygotes with elevated amyloid detected by cerebrospinal fluid biomarkers or amyloid PET).
“The later agent is studied in asymptomatic individuals at risk of developing AD (APOE4 homozygotes or APOE4 heterozygotes with elevated amyloid, detected by cerebrospinal fluid [CSF] biomarkers or amyloid PET).45”
From Current and Future Treatments in Alzheimer Disease: An Update (2020) · cites this paper as [45]
ABvac40 is evaluated in a phase 2 study as the first active vaccine against the C-terminal end of Aβ40.
“ABvac40 is evaluated in a phase 2 study, as the first active vaccine against the C-terminal end of Aβ40.”
From Current and Future Treatments in Alzheimer Disease: An Update (2020) · cites this paper as [59]
In a phase 1 study with patients with mild to moderate Alzheimer disease aged 50 to 85 years, neither incident vasogenic edema nor microhemorrhages were identified, and specific anti-Aβ40 antibodies were developed in 92% of individuals receiving ABvac40 injections.
“A phase 1 study was conducted with patients with mild to moderate AD aged 50 to 85 years. Neither incident vasogenic edema nor microhemorrhages were identified. Specific anti-Aβ40 antibodies were developed in the 92% of the individuals receiving injections of ABvac40.59”
From Current and Future Treatments in Alzheimer Disease: An Update (2020) · cites this paper as [59]
Six active immunotherapy agents are currently studied in phase 1, 2, and 3 clinical trials: CAD106, ABvac40, GV1001, ACC-001, UB-311, and Lu AF20513.
“Six active immunotherapy agents are currently studied in phase 1, 2, and 3 clinical trials:”
From Current and Future Treatments in Alzheimer Disease: An Update (2020) · cites this paper as [45]
CAD106 is an active Aβ immunotherapeutic agent studied in preclinical Alzheimer disease under the Alzheimer prevention initiative generation program, which comprises 2 phase 3 studies evaluating safety and efficacy of CAD106 and umibecestat in asymptomatic individuals at risk of developing Alzheimer disease.
“CAD106 is an active Aβ immunotherapeutic agent, is studied in preclinical AD under the umbrella of the Alzheimer prevention initiative generation program, which comprises 2 phase 3 studies that evaluate simultaneously the safety and efficacy of CAD106 and umibecestat in asymptomatic individuals at risk of developing AD (60-75 years of age, APOE4 homozygotes, or APOE4 heterozygotes with elevated Am”
From Current and Future Treatments in Alzheimer Disease: An Update (2020) · cites this paper as [45]
Six active immunotherapy agents are currently studied in phase 1, 2, and 3 clinical trials: CAD106, ABvac40, GV1001, ACC-001, UB-311, and Lu AF20513.
“Six active immunotherapy agents are currently studied in phase 1, 2, and 3 clinical trials:”
From Current and Future Treatments in Alzheimer Disease: An Update (2020) · cites this paper as [59]
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- Authors
- Lopez Lopez, C., Tariot, P. N., Caputo, A., Langbaum, J. B., Liu, F., Riviere, M., Langlois, C., Rouzade‐Dominguez, M., Zalesak, M., Hendrix, S., Thomas, R. G., Viglietta, V., Lenz, R., Ryan, J. M., Graf, A., & Reiman, E. M.
- Affiliations
- Novartis Pharma AG Basel Switzerland
- Banner Alzheimer’s Institute (US)
- Novartis (Switzerland) (CH)
- Novartis (United States) (US)
- Pentara Corporation Millcreek UT USA
- University of California San Diego (US)
- Amgen (United States) (US)
- Rodin Therapeutics (United States) (US)
- Corresponding author
- Graf, Ana
- ORCID
- Venue
- Alzheimer's & Dementia: Translational Research & Clinical Interventions
- Publisher
- Wiley
- Published
- 2019-01
- Volume
- 5
- Issue
- 1
- Pages
- 216-227
- ISSN
- 2352-8737 (ISSN-L)
- PMC
- PMC6562315
- OpenAlex
- W2950058512
- Cited by
- 116
- References
- 51
- Citations by year
- 2026: 6 · 2025: 14 · 2024: 11 · 2023: 14 · 2022: 24 · 2021: 22 · 2020: 19 · 2019: 6
- FWCI
- 2.09
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Alzheimer s & Dementia Translational Research & Clinical Interventions (publishedVersion, cc-by-nc-nd)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Funders
- Novartis Pharma
- Amgen
- Banner Alzheimer’s Foundation
- National Institute on Aging (1UF1AG0461501)
- National Institutes of Health
- Alzheimer's Association
- Foundation for Biomedical Research and Innovation
- Topics
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Pharmacology › Cholinesterase and Neurodegenerative Diseases
- Keywords
- Alzheimer's disease prevention, preclinical Alzheimer's disease, amyloid-beta, BACE1 inhibitors, amyloid hypothesis, mild cognitive impairment, dementia, APOE ε4, amyloid PET, Clinical Dementia Rating, biomarkers, long-term treatment safety
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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