Treatment Trials

8 Clinical Trials for Various Conditions

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COMPLETED
18-Month Study of Memory Effects of Curcumin
Description

This project is designed to study the effects of the dietary supplement curcumin on age-related cognitive impairment. In particular, the study seeks to determine the effects of curcumin on cognitive decline and the amount of abnormal amyloid protein in the brain. Genetic risk will also be studied as a potential predictor of cognitive decline. Subjects will be randomly assigned to one of two treatment groups: either a placebo twice daily or the curcumin supplement (Theracurmin®, containing 90 mg of curcumin). The investigators expect that the volunteers receiving the curcumin supplement will show less evidence of decline after 18 months than those receiving the placebo. The investigators predict that cognitive decline and treatment response will vary according to genetic risk for Alzheimer's. The investigators will study subjects with memory complaints aged 50-90 years. Initially, subjects will undergo a clinical assessment, an MRI and a blood draw to determine genetic risk and to rule out other neurodegenerative disorders linked to memory complaints. Subsequently, subjects will undergo an -(1-{6-\[(2-\[F-18\]fluoroethyl)(methyl)amino\]-2-naphthyl}ethylidene)malononitrile (FDDNP) PET scan and a baseline neuropsychological assessment to confirm a diagnosis of MCI or normal aging. Once enrolled, subjects will begin taking the supplement (either curcumin or a placebo). Some of the initial subjects will be asked to return every three months for regular MRIs. Every 6 months, subjects will also receive neuropsychological assessments. At the conclusion of the study, subjects will be asked to complete a final neuropsychological assessment, MRI scan, PET scan and blood draw. Additional blood will be drawn at baseline and at 18 months and frozen to assess inflammatory markers if cognitive outcomes are positive. FDDNP-PET scans will be used to measure the amount of abnormal amyloid plaque- and tau tangle-proteins in the brain; the MRIs will be used to monitor supplement side effects and measure brain structure; the neuropsychological assessments will monitor rates of cognitive decline; the blood draws will be used to determine genetic risk and to test levels of inflammatory markers.

COMPLETED
Tricaprilin In Age-Associated Memory Impairment
Description

The purpose of this study is to determine whether tricaprilin, a compound that increases energy availability in the brain, improves memory in older adults with "normal" loss of memory abilities since early adult life.

COMPLETED
Anti-Inflammatory Treatment for Age-Associated Memory Impairment: A Double-Blind Placebo-Controlled Trial
Description

This project is designed to study whether anti-inflammatory drugs, such as celecoxib, may delay age-related mental decline. We are also looking at genetic risk and brain structure as potential predictors of mental decline. We believe people with age-associated memory impairment who take celecoxib will show less evidence of mental decline than those receiving placebo (an inactive pill) after 18 months. We expect that brain structure at the start of the study, memory performance as indicated by tests, and age will be additional predictors of mental decline. We also predict that cognitive decline (i.e., decline in thinking and memory) and treatment response will vary according to genetic factors that may correlate with the age at which dementia begins. We believe other variables such as prior educational achievement, memory capability at the outset of the study, and gender may influence mental decline and treatment response. We will study people with age-associated memory impairment (mild memory complaints, decreased performance in selected memory tests), between 40 and 90 years of age. The subjects will be randomly (i.e., by a process similar to flipping a coin) assigned to treatment groups. The subjects will receive either an inactive substance (placebo) or celecoxib (400 mg/day). The subjects will receive a magnetic resonance imaging (MRI) scan, FDG PET scan, routine laboratory blood tests, electrocardiogram and cognitive tests. They will be followed for approximately 18 months and asked to return at specific intervals for follow-up testing. Measures of brain structure will be derived from baseline MRI scans and metabolic activity from PET scans, and blood will be drawn and tested to determine which forms (genotypes) of certain genetically determined cellular components the patient has.

COMPLETED
Hormone and Information Processing Study
Description

The purpose of this study is to examine the effects of testosterone (T) replacement on changes in thinking and memory, as well as mood in older men with mild cognitive impairment (MCI) and low T levels. The study will also examine whether taking testosterone has effects on biological markers related to Alzheimer's disease.

COMPLETED
Effect of BrainPhyt High Dose on Cognitive Function in Healthy Older Individuals
Description

The purpose of this study is to evaluate if BrainPhyt, a microalgae based ingredient may affect cognitive function parameters in older healthy individuals with evidence of age-related cognitive decline. In a double blind, randomized manner, 40 free living males and females between 55 to 75 years with age-associated memory decline will ingest Brainphyt supplement or Placebo for 12 weeks. Cognitive function battery will be realized after 4 and 12 weeks of supplementation.

COMPLETED
Cognitive Effects of Citicoline in Men and Women With Age-Associated Memory Impairment
Description

The objective of this trial is to determine the effects of citicoline on cognitive performance in healthy Men and Women with Age-Associated Memory Impairment compared to a placebo.

Conditions
COMPLETED
A Safety and Efficacy Study of Ispronicline (TC-1734-112) in Subjects With Age Associated Memory Impairment (AAMI)
Description

The purpose of this Phase II study is to evaluate the efficacy and safety of ispronicline (TC-1734-112) compared to placebo (inactive substance pill) in patients with age associated memory impairment (AAMI). AAMI is characterized as cognitive impairment including memory loss and poor concentration associated with aging.

COMPLETED
Hormones and Cognition in the Menopausal Transition
Description

The purpose of this study is to determine if the menopausal transition is associated with subjective and objective cognitive declines that ameliorate in menopause. The investigators hypothesize that perimenopause is associated with both subjective memory complaints and objective declines in attentionally mediated cognitive tasks. The investigators also hypothesize that this is time-limited. The investigators predict that as women transition from early perimenopause to late perimenopause their performance on attentionally mediated and verbal memory tasks will decline, and that as they transition from late perimenopause to menopause, their performance will improve.