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A clinical trial (also called clinical research) is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings. The Ethnic Elders Care Dementia Clinical Trials Database is a listing of research on medications for Alzheimer's disease and related disorders compiled from the U.S. Food and Drug Administration (FDA) , the National Institute on Aging (NIA) and  the NIA's Alzheimer's Disease Education and Referral (ADEAR) Center.


Important Notice: Ethnic Elders Care Network does not provide medical advice nor promote any product or service. The contents are for informational purposes only and are not intended to substitute for professional medical advice, diagnosis or treatment. Always seek advice from a qualified physician or health care professional about any medical concern, and do not disregard professional medical advice because of anything you may read on this web site.

 MEDICATIONS CURRENTLY IN CLINICAL TRIALS: RESULTS (listed alphabetically):
NAME: ABT 418
FDA PHASE: Discontinued
NAME: Acetyl-l-carnitine HCI
OTHER NAMES: ALCAR
FDA PHASE: Discontinued
ROLE IN ALZHEIMER'S DISEASE: Lessen cognitive deterioration
NAME: AF 102B
OTHER NAMES: cevimeline HCL, Evoxac™
FDA PHASE: Discontinued
ROLE IN ALZHEIMER'S DISEASE: Improve neuronal responsiveness to neurotrophic factors.
NAME: Alpha-tocopherol
OTHER NAMES: Vitamin E
FDA PHASE: Recruiting
ROLE IN ALZHEIMER'S DISEASE: Thought to prevent brain cell damage by destroying toxic free radicals.
NAME: Alzhemed™
FDA PHASE: Phase II/IIa/IIb
MECHANISMS: Inhibit Ab fibrillization, binds and reduces soluble Ab
ROLE IN ALZHEIMER'S DISEASE: Designed to prevent amyloid formation and deposition in the brain, and thus modify the course of AD. Alzhemed™ is expected to act on two levels: firstly to prevent and stop the formation and deposition of amyloid fibrils in the brain as well as to bind to soluble Ab, and secondly to to inhibit the inflammatory response associated with amyloid build-up in AD.
NAME: AN 1792
OTHER NAMES: AIP 001
FDA PHASE: Discontinued
ROLE IN ALZHEIMER'S DISEASE: AN-1792 is a synthetic form of the 42 amino acid beta amyloid peptide. It is hypothesized that immunization with AN-1792 can prevent or reverse the development of the neuropathological hallmarks of Alzheimer's diseases, including extensive amyloid plaque formation, neuritic dystrophy, synaptic loss and gliosis.
NAME: Atorvastatin
OTHER NAMES: Lipitor™
FDA PHASE: Phase II/IIa/IIb
ROLE IN ALZHEIMER'S DISEASE: A multi-center analysis of over 60,000 patients indicated a decreased prevalence of AD in patients taking lovastatin and pravastatin, two statin drugs commonly used in lowering cholesterol. Several possible roles of statins in AD have been proposed, see our drug sheet on statins.
NAME: Besipirdine HCl
OTHER NAMES: HP 749
FDA PHASE: Discontinued
NAME: Beta- & Gamma-Secretase Inhibitors
FDA PHASE: Preclinical
ROLE IN ALZHEIMER'S DISEASE: Beta-secretase and gamma-secretase are two proteases that cleave amyloid precursor protein, producing amyloid beta-peptide. Inhibiting these enzymes might reduce the burden of amyloid beta-peptide in AD patients' brains, which might then slow the progression of the disease.
NAME: Cerebrolysin
FDA PHASE: Phase II/III
MECHANISMS: Neotrophic Agents
ROLE IN ALZHEIMER'S DISEASE: Cerebrolysin is believed to mimic a naturally occuring growth factor, thus generating or supporting the growth of brain cells.
NAME: Citalopram
OTHER NAMES: Celexa
FDA PHASE:Aprroved for treatment of depression
MECHANISMS: Selective Serotonin Reuptake Inhibitor
ROLE IN ALZHEIMER'S DISEASE: May improve agitation and physical or verbally abusive behaviors in AD patients by pharmacologically stimulate serotonin receptor-mediated synaptic responses.
NAME: CX516
OTHER NAMES: Ampalex
FDA PHASE: Phase II/IIa/IIb
MECHANISMS: AMPAkines
ROLE IN ALZHEIMER'S DISEASE: May improve cognitive function in AD patients by pharmacologically stimulating AMPA receptor-mediated synaptic responses (a type of “docking site” that attaches the specialized messenger chemical glutamate). Reported to enhance memory performance in healthy elderly subjects.
NAME: Cyclophosphamide
OTHER NAMES: Cytoxan
FDA PHASE: Phase III
MECHANISMS: anti-inflammatory
ROLE IN ALZHEIMER'S DISEASE: May slow the rate of cognitive deterioration by decreasing inflammation in the brain.
NAME: Dapsone
OTHER NAMES: Avlosulfon
FDA PHASE: Phase II/IIa/IIb
ROLE IN ALZHEIMER'S DISEASE: As an anti-inflammatory drug, Dapsone might slow the progression of Alzheimer Disease.
NAME: Donepezil
OTHER NAMES: Aricepts™
FDA PHASE: FDA approved
MECHANISMS: cholinesterase inhibitors
ROLE IN ALZHEIMER'S DISEASE: Improves cognition, global function, and activities of daily living.
NAME: Eptastigmine
OTHER NAMES: MF 201
FDA PHASE: Discontinued
ROLE IN ALZHEIMER'S DISEASE: Improve cognition.
NAME: Estrogen
OTHER NAMES: Premarin™
FDA PHASE: Phase III
ROLE IN ALZHEIMER'S DISEASE: Several epidemiological studies suggests the use of estrogen in postmenopausal women may delay the onset or risk of AD.
NAME: Exelon™
OTHER NAMES: Rivastigmine tartrate
FDA PHASE: FDA approved
MECHANISMS: cholinesterase inhibitors
ROLE IN ALZHEIMER'S DISEASE: It improves cognition, participation in activities of daily living, and global evaluation ratings in patients with mild to moderately severe Alzheimer's disease.
NAME: FJ960
OTHER NAMES:
FDA PHASE: Phase II
MECHANISMS: piperazine derivative that releases somatostatin from nerve terminals in the hippocampus
ROLE IN ALZHEIMER'S DISEASE: Improve cognitive function in mild/moderate AD.
NAME: Galantamine
OTHER NAMES: Reminyl™
FDA PHASE: FDA approved
MECHANISMS: cholinesterase inhibitor
ROLE IN ALZHEIMER'S DISEASE: Improve cognitive function in mild/moderate AD.
NAME: GT 1061
FDA PHASE: IND filed
MECHANISMS: novel mechanisms, but is related to some nitrates and thiazoles.
ROLE IN ALZHEIMER'S DISEASE: improved learning and memory in animals in which the cholinergic systems of the forebrain had been destroyed. comparable to Aricept in efficacy.

NAME: Huperzine A
FDA PHASE: Not FDA regulated
ROLE IN ALZHEIMER'S DISEASE: Shows promise as an acetylcholinesterase inhibitor, similar to but potentially more potent than tacrine or donepezil. May also have neuroprotective effects.
NAME: Ibuprofen
OTHER NAMES: Advil™, Motrin™, Nuprin™
FDA PHASE: Phase III
ROLE IN ALZHEIMER'S DISEASE: May aid in preventing or delaying the onset of Alzheimer's disease by decreasing inflammation in the brain.
NAME: Idebenone
FDA PHASE: Discontinued
ROLE IN ALZHEIMER'S DISEASE: Improve cognitive and non-cognitive symptoms in mild/moderate AD. Protect cells from beta amyloid induced oxidative stress.
NAME: Leuprolide
OTHER NAMES: Lupron Depot™, Lupron™, Viadur™
FDA PHASE: Phase II/IIa/IIb
ROLE IN ALZHEIMER'S DISEASE: May improve cognitive function and slow the progression of Alzheimer's disease. For more on underlying rationale, see ARF news story
NAME: Linopirdine
OTHER NAMES: DuP996
FDA PHASE: Discontinued
ROLE IN ALZHEIMER'S DISEASE: Improvement of cognitive symptoms.
NAME: LU25-109
FDA PHASE: Discontinued
NAME: Melatonin
FDA PHASE: Not FDA regulated
ROLE IN ALZHEIMER'S DISEASE: A number of studies have documented disturbances in circadian rhythm associated with Alzheimer's disease, resulting in changes of body temperature, hormonal concentrations, sleep and wakefulness patterns, and rest- activity cycles. These cycles are regulated by the daily rise and fall of melatonin levels, and as one of the symptoms associated with the aging process has been a decline in the amplitude of the melatonin rhythm, there is currently interest in using melatonin to treat circadian disturbances in Alzheimer's disease. In both in vivo and in vitro experiments melatonin has been shown to reduce lipid peroxidation and oxidative damage to nuclear DNA. A variety of studies also suggest melatonin may inhibit Abeta toxicity. Some researchers hypothesize that an age- related decline in melatonin could be a cause of Alzheimer's, but it is just as probable that the disruption of the melatonin cycle is the result of an underlying disease process.
NAME: Memantine
OTHER NAMES: Ebixa™, Namenda™
FDA PHASE: FDA approved
MECHANISMS: NMDA receptor antagonist
ROLE IN ALZHEIMER'S DISEASE: Improves cognitive, social and motor impairment.
NAME: Metrifonate
FDA PHASE: Discontinued
ROLE IN ALZHEIMER'S DISEASE: Improve cognition and behavioral symptoms in mild/moderate AD.
NAME: Milameline
OTHER NAMES: CI 979
ROLE IN ALZHEIMER'S DISEASE: Enhances cognition. Appears to be well tolerated.
NAME: MKC-231
FDA PHASE: Phase II/IIa/IIb
ROLE IN ALZHEIMER'S DISEASE: Cholinergic signalling is sharply reduced early in the course of AD, MKC-231 may increase the amount of choline available to synthesize acetylcholine.
NAME: Naproxen
OTHER NAMES: Aleve™, Anaprox™, Naprosyn™
FDA PHASE: Phase III
MECHANISMS: Anti-inflammatory
ROLE IN ALZHEIMER'S DISEASE: May be useful in the treatment of the inflammatory process in Alzheimer's disease.
NAME: Nefiracetam
FDA PHASE: Phase II/IIa/IIb
ROLE IN ALZHEIMER'S DISEASE: May improve cognitive function in AD patients by activating central cholinergic transmission.
NAME: NeoTrofin
OTHER NAMES: AIT-082
FDA PHASE: Phase II/III
MECHANISMS: Neotrophic Agents
ROLE IN ALZHEIMER'S DISEASE: General improvement in mild-moderately demented Alzheimer's disease patients.
NAME: NS2330
FDA PHASE: Phase II/IIa/IIb
ROLE IN ALZHEIMER'S DISEASE: The compound enhances the function of the neurotransmitters acetylcholine, noradrenaline and dopamine, which are all impaired in Alzheimer's patients.
NAME: Olanzapine
OTHER NAMES: Zyprexa
FDA PHASE: Approved for treatment
ROLE IN ALZHEIMER'S DISEASE: May improve agitation and physical or verbally abusive behaviors in AD patients by pharmacologically stimulate  receptor-mediated synaptic responses.
NAME: Phenserine
FDA PHASE: Phase II/IIa/IIb
ROLE IN ALZHEIMER'S DISEASE: Improve cognition.
NAME: Physostigmine Salicylate
OTHER NAMES: Synapton
FDA PHASE: Discontinued
ROLE IN ALZHEIMER'S DISEASE: Improvment of short-term memory.
NAME: Propentofylline
OTHER NAMES: HWA 285
ROLE IN ALZHEIMER'S DISEASE: General improvement in mild-moderately demented Alzheimer's disease patients.
NAME: Rofecoxib
OTHER NAMES: Vioxx™
FDA PHASE: Phase III
MECHANISMS: anti-inflammatory
ROLE IN ALZHEIMER'S DISEASE: May slow the rate of cognitive deterioration by decreasing inflammation in the brain.
NAME: Sabeluzole
OTHER NAMES: R58735
FDA PHASE: Discontinued
NAME: SB 202026
OTHER NAMES: Memric, Sabcomeline
FDA PHASE: Discontinued
ROLE IN ALZHEIMER'S DISEASE: Reduce symptoms in mild/moderate Alzheimer.
NAME: SB 271046
OTHER NAMES:
FDA PHASE: Phase I 
MECHANISMS: 5-hydroxytryptamine 6 receptor antagonist
ROLE IN ALZHEIMER'S DISEASE: Reduce symptoms in Alzheimer's disease.
NAME: Selenium
OTHER NAMES:
FDA PHASE: Recruiting
MECHANISMS: Neuroprotective
ROLE IN ALZHEIMER'S DISEASE: May  protect brain cells from damage and  may decrease  risk of getting Alzheimer's Disease.
NAME: Statins
FDA PHASE: Phase II/IIa/IIb
ROLE IN ALZHEIMER'S DISEASE: A multi-center analysis of over 60,000 patients indicated a decreased prevalence of AD in patients taking lovastatin and pravastatin, two statin drugs commonly used in lowering cholesterol. Reductions in cholesterol by statins might alter APP metabolism and thus reduce the production of A-beta. Statins have also been shown to have immunomodulatory effects, blocking the ability of a cytokine called interferon-gamma (IFN-gamma) to activate T- cells. Statins might therefore have a neuro-protective effect by lowering inflammation. Several studies have also indicated that therapy with statins may reduce lipoprotein oxidation and ameliorate free radical injury.
NAME: Suritozole
OTHER NAMES: MD 26,479
FDA PHASE: Discontinued
ROLE IN ALZHEIMER'S DISEASE: An inverse GABA aganoist with cognitive enhancement properties.
 
NAME: Tacrine
OTHER NAMES: Cognex™
FDA PHASE: FDA approved
MECHANISMS: Acetylcholinesterase inhibitor
ROLE IN ALZHEIMER'S DISEASE: Increase cognition in mild to moderately demented Alzheimer's disease.
NAME: Tacrine
OTHER NAMES: Cognex™
FDA PHASE: FDA approved
MECHANISMS: Acetylcholinesterase inhibitor
ROLE IN ALZHEIMER'S DISEASE: Increase cognition in mild to moderately demented Alzheimer's disease.
NAME: TC-1734
OTHER NAMES: Tagacept
FDA PHASE: Phase I
MECHANISMS: Nicotinic receptor agonist
ROLE IN ALZHEIMER'S DISEASE: Positive effects on memory and learning as well as robust neuroprotective activity.
NAME: Valproate
OTHER NAMES: Depakene (valproic acid or sodium valproate), Depakote (divalproex sodium)
FDA PHASE: Phase III
ROLE IN ALZHEIMER'S DISEASE: Potential therapy for agitation in AD patient.

Links to other dementia research websites

http://www.alzheimers.org/trials/index.html

http://www.clinicaltrials.gov/

http://www.clinicaltrials.gov/ct/info/resources

http://clinicaltrials.gov/ct/action/GetStudy

http://www.centerwatch.com

 

 

 

 

 

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