Alzheimer’s disease prevention: from risk factors to early intervention

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

ISSN: 1758-9193