Coric, Vladimir, Salloway, Stephen, van Dyck, Christopher H., Dubois, Bruno, Andreasen, Niels, Brody, Mark, Curtis, Craig, Soininen, Hilkka, Thein, Stephen, Shiovitz, Thomas, Pilcher, Gary, Ferris, Steven, Colby, Susan, Kerselaers, Wendy, Dockens, Randy, Soares, Holly, Kaplita, Stephen, Luo, Feng, Pachai, Chahin, Bracoud, Luc, Mintun, Mark, Grill, Joshua D., Marek, Ken, Seibyl, John, Cedarbaum, Jesse M., Albright, Charles, Feldman, Howard H., Berman, Robert M.

Importance: Early identification of Alzheimer disease (AD) is important for clinical management and affords the opportunity to assess potential disease-modifying agents in clinical trials. To our knowledge, this is the first report of a randomized trial to prospectively enrich a study population with prodromal AD (PDAD) defined by cerebrospinal fluid (CSF) biomarker criteria and mild […]

Leoutsakos, Jeannie-Marie S., Muthen, Bengt O., Breitner, John C. S., Lyketsos, Constantine G.

Objective: We examined the effects of non-steroidal anti-inflammatory drugs on cognitive decline as a function of phase of pre-clinical Alzheimer disease.; Methods: Given recent findings that cognitive decline accelerates as clinical diagnosis is approached, we used rate of decline as a proxy for phase of pre-clinical Alzheimer disease. We fit growth mixture models of Modified […]

Dockens, Randy, Wang, Jun-Sheng, Castaneda, Lorna, Sverdlov, Oleksandr, Huang, Shu-Pang, Slemmon, Randy, Gu, Huidong, Wong, Oi, Li, Hewei, Berman, Robert M., Smith, Christina, Albright, Charles F., Tong, Gary

Background and Objectives: Avagacestat is an orally active γ-secretase inhibitor that selectively inhibits amyloid β (Aβ) synthesis in cell culture and animal models. The objective of the current study was to assess the pharmacokinetics, pharmacodynamics, safety and tolerability of multiple doses of avagacestat over 28 days in healthy young men and elderly men and women […]

Breitner, J, Baker, L, Drye, L, Alzheimer's Disease Anti-inflammatory Prevention Trial Research Group,

Objectives: The Alzheimer’s Disease Anti-inflammatory Prevention Trial Follow-up Study (ADAPT-FS) was designed to evaluate the efficacy of naproxen and celecoxib for the primary prevention of Alzheimer’s disease (AD) several years after cessation of treatment in ADAPT.; Methods: ADAPT was a randomized, double-masked, multicenter clinical trial of naproxen or celecoxib vs placebo (1:1:1.5 assignment ratio) at […]

Breitner, John C., Baker, Laura D., Montine, Thomas J., Meinert, Curtis L., Lyketsos, Constantine G., Ashe, Karen H., Brandt, Jason, Craft, Suzanne, Evans, Denis E., Green, Robert C., Ismail, M. Saleem, Martin, Barbara K., Mullan, Michael J., Sabbagh, Marwan, Tariot, Pierre N.

Background: Epidemiologic evidence suggests that nonsteroidal anti-inflammatory drugs (NSAIDs) delay onset of Alzheimer’s dementia (AD), but randomized trials show no benefit from NSAIDs in patients with symptomatic AD. The Alzheimer’s Disease Anti-inflammatory Prevention Trial (ADAPT) randomized 2,528 elderly persons to naproxen or celecoxib versus placebo for 2 years (standard deviation = 11 months) before treatments […]

Meinert, Curtis L., McCaffrey, Lee D., Breitner, John C. S.

Background: The Alzheimer’s Disease Anti-inflammatory Prevention Trial (ADAPT) was designed to address whether non-steroidal anti-inflammatory drugs (NSAIDs) can prevent or delay the onset of Alzheimer’s disease (AD).; Methods: ADAPT was a randomized, double-placebo-controlled, multicenter chemoprevention trial conducted at six U.S. dementia research clinics. At entry, participants were required to test “normal” on a battery of […]

Trzepacz, Paula T., Cummings, Jeffrey, Konechnik, Thomas, Forrester, Tammy D., Chang, Curtis, Dennehy, Ellen B., Willis, Brian A., Shuler, Catherine, Tabas, Linda B., Lyketsos, Constantine

Background: Mibampator, an amino-3-hydroxy-5-methyl-4-isoxazole propionic acid receptor potentiator, was evaluated for treatment of agitation and aggression (A/A) in Alzheimer’s disease (AD).; Methods: Outpatients (n = 132) with probable AD and A/A randomized to 12 weeks of double-blind treatment with 3-mg po mibampator or placebo were assessed using the 4-domain A/A subscale of the Neuropsychiatric Inventory […]

Reckess, Gila Z., Brandt, Jason, Luis, Cheryl A., Zandi, Peter, Martin, Barbara, Breitner, John C. S.

Compared with in-person assessment methods, telephone screening for dementia and other cognitive syndromes may improve efficiency of large population studies or prevention trials. We used data from the Alzheimer’s Disease Anti-Inflammatory Prevention Trial to compare performance of a four-test Telephone Assessment Battery (TAB) that included the Telephone Interview for Cognitive Status (TICS) to that of […]