Table 3.
Completed and ongoing Alzheimer prevention randomized controlled trials
| Name and NCT | Status | Intervention | Inclusion | N | Primary evaluation criterion |
Secondary evaluation criteria |
Treatment duration | Dates |
|---|---|---|---|---|---|---|---|---|
| Alzheimer Disease Prevention Trial (PREPARE AD) NCT00000176 |
Completed | Estrogens | ≥65 y, healthy female | NA | Onset of memory loss | — | 3 y | 1999-Sept 2007 |
| Alzheimer’s Disease Anti-Inflammatory Prevention Trial ADAPT NCT00007189 | Completed | Naproxen, celecoxib | ≥70 y, first degree relative with dementia | 2625 | NR | NR | 5–7 y | Jan 2001-Jan 2007 |
| The Ginkgo Evaluation of Memory (GEM) study NCT00376510 | Completed | Tanakan | ≥70 y, SMC, MMSE>25, CDR 0 to 0.5 | 2878 | Conversion to AD | Rate of cognitive decline | 60 mo | 2001–2009, completed |
| Prevention of Dementia by Intensive Vascular Care (PreDIVA) ISRCTN29711771 | Ongoing | CV prevention by nurse monitoring, multidomain intervention, cluster randomization | 70–78 y, MMSE >23, not demented | 3535 | dementia, disability | Cognitive decline (MMSE, VAT), depression, cardiovascular events |
6y | Start: 2006 |
| The Multidomain Alzheimer Preventive Trial (MAPT) NCT00672685 |
Completed | Omega-2 fatty acids; multidomain intervention, placebo; factorial design |
≥70 y; frail at least one cirteria: SMC, difficulty performing one ADL, or walking speed≤0,77 m/s, not AD, MMSE≥25 |
1680 | Cognitive function (Grober & Buschke) |
FDG-PET; MRI; A-beta PET (AV45) |
36 mo | 2008–2014 |
| Exercise for Cognition and Everyday Living for Seniors With Memory Complaints (EXCEL) NCT00958867 |
Completed | Aerobic training, resistance training, strech and relaxation |
Seniors with subjective memory complaint; MMSE>24, MOCA<26; ≥70 y |
86 | Cognitive performance | Everyday problem solving ability | 6 mo | Aug 2009-Mar 2010 |
| The Finnish Geriatric Intervention Study to prevent to Cognitive Impairment and Disability (FINGER) NCT01041989 |
Ongoing | Lifestyle | Increased dementia risk; 60–77 year-old, MMSE 20–26, delayed recall ≤75%; word list memory 14 ≤ 19; dementia risk factor>6 | 1200 | NTB, stroop, TMT A&B at 7 years |
Zung depression ADCS-ADL, RAND-36 (QoL) | 2y | Sept 2009-Dec 2018 |
| ASPirin in Reducing Events in the Elderly (ASPREE). NCT01038583 |
Ongoing | aspirin | Elderly, that is, ≥65 y for African American and hispanic (70 for caucasian); without dementia, severe HY, and able to perform 6 Katz ADLs |
19,000 | Death from any cause or incident, dementia, or persistent physical disability. | Jan 2010-Jan 2018 | ||
| Effect of simvastatin on biomarkers (SimBio) NCT01142336 |
Ongoing | Simvastatin | 45–64 y, cognitively normal (MMSE>26) logical memory recall.6, CDR = 0 |
120 | CSF: A-beta, tau and BDNF |
Markers of inflamation of oxidative stress in CSF |
1 y | June 2010–Oct 2015 |
| Ginkgo Biloba Prevention Trial in older individuals NCT00010803 |
Completed | Ginko | ≥75 y, nondemented | 3069 | Incidence of dementia, specifically Alzheimer’s disease based on DSM-IV criteria as determined by an expert panel of clinicians using an adjudication process. |
Incidence of vascular disease, changes in cognitive function scores over time (CDR, MMSE, ADAS), total mortality, and changes in functional status. |
6 y on average | Oct 2010–July 2011 |
| TOP-COG ISRCTN67338640 |
Completed | Simvastatin | Down syndrome aged >50 years |
60 | Pilot study: feasibility, patient inclusion, and retention |
Neuropsychological tests battery |
Up to 2 y | Apr 2012–March 2014 |
| DIAN-TU NCT01760005 | Ongoing | Ongoing Gantenerumab (s.c.), solanezumab (i.v.) |
PS and mutation carriers or belonging to family −15 to +10 years of parental symptom onset, normal cognition, or mild impairment CDR 0 to 1 |
210 | Gantenerumab arm: firillar amyloid deposit (11C PIB-PET) Solanezumab: A-beta CSF concentration |
Other biomarker: CSF tau MRI, FDG-PET, exploratory clinical measures: CDR, MMSE, NPI, FAQ |
2 y | Dec 2012–Mar 2017 |
| Pilot Study: lipoic acid and omega-3 fatty acids for Alzheimer’s prevention NCT01780974 |
Ongoing | Lipoic acid and omega-3 fatty acids |
≥55 years Nondemented: Montreal Cognitive Assessment > 26 and Clinical Dementia Rating = 0 Diagnosis of Essential Hypertension with systolic 90–160mmHg and diastol |
30 | TMT-B | Brain hyperintensity volume on brain MRI |
1 year | Apr 2013–Sept 2015 |
| TOMMOROW NCT01931566 |
Ongoing | Pioglitazone | 65–83 y; CDR = 0; One memory test >−1,5 SD, MMSE>25 |
5800 | Time to MCI | Cognitive test battery: episodic memory, executive function, language, attention; ADCS-ADL |
48 mo | Aug 2013–Apr 2019 |
| Alzheimer prevention through exercise APEX NCT02000583 |
Ongoing | Aerobic exercise | Clinical Dementia Rating 0 (nondemented) Age ≥65 years Florbetapir PET evidence of cerebral amyloidosis |
100 | Brain amyloid load (florbetapir) |
Structural brain MRI, cognition |
52 wk | Nov 2013–Jan 2018 |
| API NCT01998841 | Ongoing | Crenezumab | Carriers of PSEN-1, E280 A mutation, non- MCI, nondemented |
300 | Composite: cognitive: world list recall, multilingual naming test, MMSE, CERAD constructional praxis, Raven progressive matrices |
Progression to MCI or dementia; change in CDR-SB, FCSRT, RBANS, CMRrl, cerebral amyloid, volumetric MRI, CSF tau |
260 wk | Dec 2013–Sep 2020 |
| Modulation of Micro- RNA Pathways by Gemfibrozil in Predementia Alzheimer Disease NCT02045056 |
Ongoing | Gemfibrozil | Men or women aged 65– 90 years 48 cognitively intact subjects, and 24 subjects with early cognitive decline (CDR 0.5) predementia |
70 | Safety, micro-RNA107 levels in blood and CSF; Beta-amyloid concentration in CSF |
FCSRT, paired asociated learning |
48 wk | Jan 2014–June 2016 |
| Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss (A4) NCT02008357 |
Ongoing | Solanezumab | MMSE, 25–30 CDR = 0; logicalmemory II: 6–18, florbetapir+, 65–85 y |
1150 | ADCS-PACC | Cognitive function index, ADCS-ADL, SUVr, CSF tau and beta- amyloid |
168 wk | Feb 2014–Apr 2020 |
| J&J-54861911 NCT02260674 |
Ongoing | JNJ-54861911 | Predementia, CDR 0 to 0.5 and either low cerebrospinal fluid (CSF) ABeta 1–42 levels or positive- amyloid PET scan |
100 | AES | Drug concentration blood ± CSF CSF A-beta, PK |
6 mo | Nov 2014–Mar 2016 |