Table 2.
Description of currently ongoing AD prevention clinical trials
| DIAN-TU | API-ADAD | A4 | TOMMORROW | API-GENERATION | EARLY | |
|---|---|---|---|---|---|---|
| Estimated enrolment | 210 | 300 | 1150 | 3494 | 1340 | 1650 |
| Target population/specific characteristics | Autosomal dominant Alzheimer’s disease (ADAD) mutation carriers or persons that have a 50% chance of carrying an ADAD mutation | Membership in PSEN1 E280A mutation carrier kindred | Cognitively normal, positive brain amyloid PET | Cognitively normal with genetic risk (TOMM40 and APOE genotype) | Cognitively normal APOE-ε4 homozygous | Cognitively normal positive amyloid |
| Age | 18–80 years | 30–60 years | 65–85 years | 65–83 years | 60–75 years | 60–85 years |
| Phase | Phase II/III | Phase II | Phase III | Phase III | Phase II/III | Phase II/III |
| Compound | Gantenerumab Solanezumab |
Crenezumab | Solanezumab | Pioglitazone | CAD106 CNP520 |
JNJ-54861911 |
| Mechanism | Anti-Aβ antibodies | Anti-Aβ antibody | Anti-Aβ antibody | PPAR-γ agonist | Aβ vaccine BACE inhibitor |
BACE inhibitor |
| Status | Ongoing, not recruiting | Active, not recruiting | Recruiting | Active, not recruiting | Recruiting | Recruiting |
| Primary outcome | Composite Cognitive Test Score | Composite Cognitive Test Score | Composite Cognitive Test Score | Time to diagnosis of mild cognitive impairment (MCI) due to AD | Time to diagnosis of MCI or dementia due to AD Composite Cognitive Test Score |
Composite Cognitive Test Score |
| Study duration | 4 years | 5 years | 3 years | 5 years | 5 years | 4.5 years |
| Trial identifier | NCT01760005 | NCT01998841 | NCT02008357 | NCT01931566 | NCT02565511 | NCT02569398 |
| Expected completion | December 2019 | September 2020 | October 2020 | July 2019 | August 2023 | May 2023 |
Source: https://clinicaltrials.gov (accessed May 2017) [45]
A4 Anti-Amyloid Treatment in Asymptomatic Alzheimer’s study, Aβ amyloid beta, AD Alzheimer’s disease, API-ADAD Alzheimer’s Prevention Initiative for Autosomal Dominant Alzheimer’s Disease, API-GENERATION A Study of CAD106 and CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease, BACE Beta-secretase, DIAN Dominantly Inherited Alzheimer Network, EARLY An Efficacy and Safety Study of JNJ-54861911 in Participants Who Are Asymptomatic at Risk for Developing Alzheimer's Dementia, PET Positron Emission Tomography, PPAR Peroxisome proliferator activated receptor, PSEN1 presenilin 1, TOMMORROW Biomarker Qualification for Risk of Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease (AD) and Safety and Efficacy Evaluation of Pioglitazone in Delaying Its Onset