The Depression in Alzheimer's Disease Study (DIADS)
Alzheimer DiseaseDepressionMajor depression afflicts approximately 25 percent of patients with AD. Depression in AD patients leads to mental suffering, behavioral disturbance (such as aggression), poor cognition, poor self-care, caregiver depression, caregiver burden, and early entry into the nursing home. Since major depression is treatable, this additional disability may be avoidable. The use of antidepressants to treat major depression in AD is supported by two studies, although a third does not show a benefit for antidepressants over placebo. Also, the safety of antidepressant treatment in depressed AD patients is poorly studied. A conclusive study showing that depression reduction in AD can be accomplished safely with antidepressant medications, and that depression reduction is associated with improvements in activities of daily living, non-mood behavioral disturbances, caregiver burden, and caregiver depression would have major clinical and cost implications for the care of the AD patient. This study is a 13-week, double blind, flexible dose, placebo controlled trial of sertraline in the treatment of outpatients with AD and co-morbid major depression. The hypothesis is that antidepressant treatment is superior to placebo in improving mood, in improving cognition, in reducing physical dependency, in reducing caregiver depression, and in reducing caregiver burden. It is also hypothesized that the degree of depression reduction is correlated with these improvements. It is further hypothesized that the safety profile of sertraline when compared to placebo is acceptable, especially with regard to risk of falls, sleep disturbance, and delirium. One hundred community residing outpatients with probable AD who also meet DSM-IV criteria for major depressive episode will be recruited into the study. They will be randomized to sertraline or placebo and followed through weekly telephone contact by an experienced clinical trials team. Outcomes will be assessed every 3 weeks, for a total of four followup data points. Scales assessing the following domains will be used: depression, cognition, behavioral disturbance, physical dependency, delirium, falls, sleep, other side effects, caregiver depression, caregiver burden, caregiver functioning, and caregiver health.
Effect of Activity on Sleep of Cognitively-Impaired Veterans
Alzheimer's DiseaseSleep DisordersSleep-activity rhythm disturbance is a prevalent, disabling symptom in cognitively-impaired (CI) elders. Their nocturnal sleep is light and inefficient with frequent awakenings. Multiple short daytime napping episodes interfere with daytime activity and functioning. Daytime disruptive behaviors, such as pacing, hitting, and cursing are related significantly to sleep-activity rhythm disturbance. Medical treatment for sleep and behavior disturbances with benzodiazepines or antipsychotic medications has proven minimally effective and has serious side effects such as impairments in cognition, memory, coordination, and balance, tolerance and severe rebound insomnia, and tardive dyskinesia.
Evaluation of Galantamine in the Treatment of Alzheimer's Disease
Alzheimer DiseaseGalantamine is an experimental drug being evaluated in the United States for the treatment of Alzheimer's disease. Results from previous clinical trials suggest that galantamine may improve cognitive performance in individuals with Alzheimer's disease. It is not a cure for Alzheimer's disease. Nerve cells in the brain responsible for memory and cognitive function communicate using a chemical called acetylcholine. Research has shown that deterioration of cells that produce acetylcholine in the brain affects thought processes. Galantamine is thought to work in two ways to increase the amount of acetylcholine available in the brain. It inhibits an enzyme that breaks down acetylcholine and it also stimulates the nicotinic receptors in the brain to release more acetylcholine.
Memory Impairment Study (Mild Cognitive Impairment Study)
Alzheimer DiseaseThe National Institute on Aging (NIA) is launching a nationwide treatment study targeting individuals with mild cognitive impairment (MCI), a condition characterized by a memory deficit, but not dementia. An NIA-funded study recently confirmed that MCI is different from both dementia and normal age-related changes in memory. Accurate and early evaluation and treatment of MCI individuals might prevent further cognitive decline, including development of Alzheimer's disease (AD). The Memory Impairment Study is the first such AD prevention clinical trial carried out by NIH, and will be conducted at 65-80 medical research institutions located in the United States and Canada. This study will test the usefulness of two drugs to slow or stop the conversion from MCI to AD. The trial will evaluate placebo, vitamin E, and donepezil, an investigational agent approved by the Food and Drug Administration for another use. Vitamin E (alpha-tocopherol) is thought to have antioxidant properties, and was shown in a 1997 study to delay important dementia milestones, such as patients' institutionalization or progression to severe dementia, by about seven months.
Agitation in Alzheimer's Disease
Alzheimer DiseaseAgitation affects 70 to 90 percent of patients with AD. Signs of agitation include verbal and physical aggressiveness, irritability, wandering, and restlessness. These behaviors often make caring for patients at home very difficult. Trazodone and haldol are two of the most commonly prescribed drugs for agitation in AD patients. Behavior management, a non drug approach, has been effective in reducing signs of agitation. Researchers have yet to compare the effectiveness of drug versus non drug therapy to treat agitation in AD patients and determine which is the best treatment. The Alzheimer's Disease Cooperative Study, with funding from the National Institute on Aging, is conducting an agitation treatment program at 21 sites in 16 States. This study will assess which of the above treatments is most effective.
Effect of Modulating Gamma Oscillations Using tACS
Alzheimer DiseaseThis study aims to implement an intervention based on multiple, individualized multifocal tACS stimulation sessions based on individual PET and MRI information in patients with amyloid-positive PET with the hope that this leads to microglia activation and decrease in cerebral amyloid and tau depositions in human patients with AD.
Vielight Neuro RX Gamma - Feasibility Pilot
Alzheimer DiseaseThis study tests the effects of the Neuro RX Gamma synchronous and asynchronous devices on the cognitive and behavioral functioning of subjects with moderate-to-severe Alzheimer's Disease. The Neuro RX Gamma is non-invasive and delivers near-infrared energy to the brain in daily treatment sessions at home. An optional substudy will involve the use of the Electroencephalogram (EEG) to assess the effect of the treatment devices on the electrical activity of the brain compared to sham.
PET Imaging of Subjects Using 124I-PU-AD
LymphomaSolid Malignancy2 moreThis is a first in-human, open-label pilot (microdose) study of the positron-emitting agent 124I-PU-AD in subjects with specific cancer types (solid malignancy, lymphoma, and/or myeloma) and/or Alzheimer's disease.
PTI-125 for Mild-to-moderate Alzheimer's Disease Patients
Alzheimer DiseaseThis is a Phase 2a, multi-center, open-label study of PTI-125 in mild-to-moderate Alzheimer's disease patients.
Vestibular Physical Therapy for People With Alzheimer Disease
Vestibular DiseasesAlzheimer Disease1 moreThe purpose of this study is to assess the tolerability and preliminary efficacy of an 8-week home-based vestibular physical therapy program in people with cognitive impairment.