For the primary hypothesis, the primary endpoint is time to relapse.
primary
—
0-24 weeks in Phase B
NCT00009217-outcome-1
NCT00009217
Severity of target symptoms at the end of Phase A as a predictor of relapse
secondary
—
0-24 weeks in Phase B
NCT00009217-outcome-2
NCT00009217
Severity of Brief Psychiatric Rating Scale psychosis and hostile suspiciousness factor scores
secondary
—
0-20 weeks in Phase A and 0-24 weeks in Phase B
NCT00009217-outcome-3
NCT00009217
MMSE and Blessed Functional Activity Scale
secondary
—
0-20 weeks in Phase A and 0-24 weeks in Phase B
NCT00010803-outcome-0
NCT00010803
Number of Participants With Incident Dementia
primary
All cause dementia based on DSM-IV criteria as determined by an expert panel of clinicians using an adjudication process. A full neuropsychological battery was administered annually, or at 6 month visit if there was a diagnosis of dementia or initiation of medication for dementia by private physician, or change in Modified Mini Mental State Exam (3MSE), Clinical Dementia Rating (CDR), or Alzheimer Disease Assessment Scale (ADAS-Cog). Decline on tests scores based on an algorithm resulted in a neurological exam and brain imaging. These data were used in the adjudication process.
Brief neuropsychological testing every 6 months, detailed testing annually, average 6.1 years follow up
NCT00010803-outcome-1
NCT00010803
Number of Participants With the Indicated Cardiovascular Disease or Mortality
Progression of Cognitive Decline in Standardized Z-score Scale. Higher Z-scores Indicate Worse Performance.
secondary
Rate of annual change by cognitive domain in standardized Z-score scale. Higher Z-scores indicate worse performance. Best score = -2.0 Z-score change per year (improvement); worse score = 2.0 Z-score change per year (decline).
6 months/annually
NCT00034762-outcome-0
NCT00034762
Change from baseline to end of treatment (Week 8) in Psychosis Cluster Score of Pathology from the Behavioral Pathology in Alzheimer's Disease (BEHAVE-AD) Rating Scale and Clinical Global Impression (CGI).
primary
—
—
NCT00034762-outcome-1
NCT00034762
Change in BEHAVE-AD total score and subscales (other than Psychosis Cluster subscale) from baseline; improvement in CGI scores during treatment; incidence of adverse events throughout study.
secondary
—
—
NCT00035204-outcome-0
NCT00035204
To measure the differences between galantamine and donepazil for sleep and attention, explore methods of measuring sleep in patients with Alzheimer's Disease (AD)and their caregivers and attention in AD patients; GI tolerance
primary
—
—
NCT00035204-outcome-1
NCT00035204
To assess the tolerability, overall effect, quality of life and safety of galantamine compared with donepezil
secondary
—
—
NCT00040378-outcome-0
NCT00040378
incidence of dementia (including Alzheimer's disease)
primary
Participants will complete a modified Telephone Interview of Cognitive Status (TIC-S) to evaluate the onset of dementia
7 to 12 years (depending on enrollment date)
NCT00040443-outcome-0
NCT00040443
15-Item Word List Delayed Recall
primary
The 15-Item Word List delayed recall score is used as a clinical measure of episodic memory, and was the primary outcome variable for this study. Episodic memory of the type addressed by delayed recall of lists and stories (i.e., in the WMS-R logical memory tests and 15-item World List recall tests) is among the earliest deficits during aging and MCI compared to other aspects of cognition (attention, reaction time, language, etc). It was decided to use the 15-item Word List delayed recall test as the primary outcome measure due to its sensitivity in the assessment of MCI.
The possible score range for the 15-item Word List Delayed Recall test is 0 to 15. A clinical improvement of MCI or dementia would be characterized by an increase in the score due to an increase in the number of words recalled.
28 Days
NCT00056316-outcome-0
NCT00056316
Beck Depression Inventory II (Beck, Steer & Brown, 1996)
primary
21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. The total continuous score can range from 0 to 63 points, with higher scores reflective of greater severity.
Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention
21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. The total continuous score can range from 0 to 63 points, with higher scores reflective of greater severity.
Post-intervention, assessed 4-14 days after final intervention session.
NCT00056316-outcome-2
NCT00056316
Negative Affect Schedule (Watson, Clark & Tellegen, 1988)
secondary
10 item self-report assessment of negative affects. Participants rate items on a scale from 1 to 5, based on the strength of emotion where 1 = "very slightly or not at all," and 5 = "extremely". The total continuous score may range from 10 to 50, with higher values indicative of stronger negative emotion.
Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention
NCT00056316-outcome-3
NCT00056316
Secondary Outcome: Negative Affect Scale (Watson, Clark & Tellegen, 1988)
secondary
10 item self-report assessment of negative affects. Participants rate items on a scale from 1 to 5, based on the strength of emotion where 1 = "very slightly or not at all," and 5 = "extremely". The total continuous score may range from 10 to 50, with higher values indicative of stronger negative emotion.
Post-intervention, assessed 4-14 days after final intervention session.
NCT00056524-outcome-0
NCT00056524
emotional control
primary
—
—
NCT00062569-outcome-0
NCT00062569
Care Recipient: Resistiveness to care; discomfort
primary
—
Baseline, post 3-week intervention, and 3-week follow-up.
NCT00062569-outcome-1
NCT00062569
Caregiver: Self-efficacy; interactive behaviors
primary
—
Baseline, post 3-week intervention, and 3-week follow-up.
NCT00062569-outcome-2
NCT00062569
Caregiver burden & satisfaction
secondary
—
Baseline, post 3-week intervention, and 3-week follow-up.
NCT00064870-outcome-0
NCT00064870
Distribute biological specimens to qualified investigators for use in their research studies.
primary
Investigators will analyze the samples and publish de-identified results. These publications will help to further the knowledge in the field of dementia and potentially lead to new therapies and targets for therapies.
Contact investigators annually for an update on progress and publication status.
NCT00066157-outcome-0
NCT00066157
Cognition: delayed recall on Buschke Selective Reminding Test; Stroop Interference condition--completion time and errors; Clinician-rated Interview Based Impression of Change
primary
—
Baseline and 1, 3, 6, 12, and 15 months
NCT00066157-outcome-1
NCT00066157
Skills of Independent Living: Physical functioning Performance (PFP)
secondary
—
Baseline and 1, 3, 6, 12, and 15 months
NCT00066157-outcome-2
NCT00066157
Bioassays (Estradiol, estrone, medroxyprogesterone, FSH, influence of ApoE genotype in responsivity to estrogen)
secondary
—
Baseline and 1, 3, 6, 12, and 15 months
NCT00071721-outcome-0
NCT00071721
Presence of Agitation and/or Psychosis Measured by the Neuropsychiatric Inventory (NPI) Combined With an Assessment of the Clinical Significance of Behavioral Change Rated by the Study Clinician
primary
NPI quantifies behavioral changes in dementia, including depression, anxiety, psychosis, agitation, and others. This is a questionnaire administered to the subject's study partner. The range of this instrument is 0 to 120 with higher numbers indicating greater impairment. To determine whether or not psychosis or agitation is present, there is no cutoff score but is based on the clinician's judgment. In the NPI, the subject responds to 'Yes' or 'No' questions. Then it is determined how often psychosis or agitation occurs and if it is mild, moderate or severe.
24 months
NCT00071721-outcome-1
NCT00071721
Cognitive Performance Assessed by the Alzheimer's Disease Assessment Scale-cognitive Subtest (ADAS-cog)
secondary
Alzheimer's Disease Assessment Scale, cognitive sub-scale in points per year (ADAS-cog) is a psychometric measure sensitive to change in mild to moderate AD. The range of this instrument is 0 to 70 with higher numbers indicating greater impairment.
24 months
NCT00071721-outcome-2
NCT00071721
Functional Performance Assessed by the Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory
secondary
Alzheimer's Disease Cooperative Study Activities of Daily Living Score (ADCS-ADL) is a structured questionnaire about activities of daily living, administered to the subject's caregiver/study partner. The range of this instrument is 0 to 78 with lower numbers indicating greater impairment.
24 months
NCT00071721-outcome-3
NCT00071721
Global Severity of Dementia Using the CDR Sum of Boxes
secondary
Clinical Dementia Rating, Sum of Boxes (CDR-SOB) is a global rating of dementia severity based on the clinician's interpretation of the history and examination. The range of this instrument is 0 to 18 with higher numbers indicating greater impairment.
24 months
NCT00071721-outcome-4
NCT00071721
Agitation Measured by the Cohen-Mansfield Agitation Inventory (CMAI), Community Version
secondary
The Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item caregiver rating questionnaire for the assessment of agitation in older persons. It includes descriptions of 29 agitated behaviors, each rated on a 7-point scale of frequency. The range of this instrument is 29 to 203 with higher numbers indicating greater impairment.
24 months
NCT00071721-outcome-5
NCT00071721
Participant's Clinical Condition or Endpoint Assessed With the ADCS-Clinical Global Impression of Change (ADCS-CGIC)
secondary
ADCS-Clinical Global Impression of Change (ADCS-CGIC) provides a means to reliably assess global change from baseline. It provides a semi-structured format to allow clinicians to gather necessary clinical information from both the participant and informant, in order to make an overall impression of clinical change. The range of this instrument is 1 to 7 with lower numbers indicating improvement and higher numbers indicating a worsened state.
24 months
NCT00074529-outcome-0
NCT00074529
Cognitive function over 12 month period; safety and tolerability
primary
—
over 12 month period
NCT00074529-outcome-1
NCT00074529
AD symptoms over a 6 month and 12 month period measured by the CIBIC + and the ADAS-Cog.
secondary
—
over a 6 month and 12 month period
NCT00082602-outcome-0
NCT00082602
The primary end point occurs at Week 8. The primary outcome measures will be tolerability and safety through rates of adverse events.
primary
—
—
NCT00082602-outcome-1
NCT00082602
The secondary end point occurs at Week 12. The secondary outcome measure will be the Mini Mental State Examination score.
secondary
—
—
NCT00083421-outcome-0
NCT00083421
Cognitive Function Scale
primary
—
—
NCT00083421-outcome-1
NCT00083421
Global Function Scale
primary
—
—
NCT00083421-outcome-2
NCT00083421
ADL Scale
secondary
—
—
NCT00083421-outcome-3
NCT00083421
Psychiatric Symptom Scale
secondary
—
—
NCT00086138-outcome-0
NCT00086138
Modfied Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (mADCS-CGIC)
primary
At each study visit, based on patient examination and caregiver interview, clinicians rated overall impression of clinical change from baseline using the modified Alzheimer's Disease Cooperative Study Clinical Global Impression of Change index (mADCS-CGIC), which in addition to the original scale incorporates a global rating of mood and associated symptoms of depression. The mADCS-CGIC uses a seven-point Likert scale, with scores ranging from 1 ("much better") to 7 ("much worse"), with a score of 4 being "no change".
Measured at Week 12
NCT00086138-outcome-1
NCT00086138
Remission According to Cornell Scale for Depression in Dementia Scale
secondary
The Cornell Scale for Depression in Dementia (CSDD), a 19-item scale measuring the severity of depression in dementia, utilizing input from both the caregiver and the participant. CSDD scores were imputed for 2 participants for week 2, 4 participants for week 4, 7 participants for week 8, and 12 participants for week 12.
Measured at Weeks 12
NCT00087789-outcome-0
NCT00087789
Safety and tolerability of three different doses of CERE-110 in subjects with mild to moderate Alzheimer's disease
primary
—
24 months
NCT00090402-outcome-0
NCT00090402
F2-isoprostane Level Urine F2-Isoprostanes
primary
F2-isoprostane is a biomarker was used as an effective indicator for detecting a decrease in systemic oxidative damage (oxidative damage in lipids). Urine F2-Isoprostanes were used to avoid ex vivo lipid peroxidation that can occur with plasma samples.
baseline, 12 months
NCT00090402-outcome-1
NCT00090402
Change in Mini-Mental State Exam (MMSE) Score From Baseline to 12 Months
primary
The MMSE is a measure of global cognitive function, and scores range from 0-30, with a lower score indicates greater cognitive impairment.
baseline, 12 months
NCT00090402-outcome-2
NCT00090402
Change in Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) Scores From Baseline to 12 Months
secondary
The Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) measures an individual's ability to carry out tasks that are important for daily living and capture functional changes. Scores for each question range from 0 (no assistance needed) to 2 (full assistance needed), and were assessed by informant interview. The combination of scores for ADL (ranging from 0-18) and IADL (0-14) is the outcome (0-32), with higher scores indicating lesser ability to carry out daily living tasks.
baseline, 12 months
NCT00095719-outcome-0
NCT00095719
tolerability
primary
—
—
NCT00095719-outcome-1
NCT00095719
safety assessments
secondary
—
—
NCT00096473-outcome-0
NCT00096473
Assessments of global and cognitive function of Severe AD patients
primary
—
—
NCT00096473-outcome-1
NCT00096473
Assessment of behavior and performance on Activity of Daily Living in severe AD patients
secondary
—
—
NCT00096473-outcome-2
NCT00096473
Assessment of caregiver burden
secondary
—
—
NCT00097916-outcome-0
NCT00097916
Neuropsychiatric Inventory
primary
—
—
NCT00097916-outcome-1
NCT00097916
Cohen Mansfield Agitation Inventory
secondary
—
—
NCT00097916-outcome-2
NCT00097916
Clinical Global Impression Scale
secondary
—
—
NCT00097916-outcome-3
NCT00097916
ADCS-ADL
secondary
—
—
NCT00097916-outcome-4
NCT00097916
Agitation/aggression domain of Neuropsychiatric Inventory (NPI)
secondary
—
—
NCT00099242-outcome-0
NCT00099242
Change in cognition from baseline at week 24
primary
—
—
NCT00099242-outcome-1
NCT00099242
Global clinical impression of change from baseline at week 24
primary
—
—
NCT00099242-outcome-2
NCT00099242
Change from baseline at week 24 in activities of daily living
secondary
—
—
NCT00099242-outcome-3
NCT00099242
Change from baseline at week 24 in behavioral symptoms
secondary
—
—
NCT00099242-outcome-4
NCT00099242
Change from baseline at week 24 in global cognitive testing
secondary
—
—
NCT00099242-outcome-5
NCT00099242
Change from baseline at week 24 in executive function
Safety will be assessed through the occurrence of clinical adverse events and the occurrence of clinically significant changes from baseline.
primary
—
—
NCT00103649-outcome-0
NCT00103649
Alzheimer's Disease assessment scale-cognitive, clinical dementia rating sum of boxes.
primary
—
—
NCT00103649-outcome-1
NCT00103649
Mini-Mental State Examination, Alzheimer's Disease assessment scale-activities of daily life.
secondary
—
—
NCT00104013-outcome-0
NCT00104013
Alzheimer's Disease assessment scale-cognitive, clinical dementia rating sum of boxes.
primary
—
—
NCT00104013-outcome-1
NCT00104013
Mini-Mental State Examination, Alzheimer's Disease assessment scale-activities of daily life.
secondary
—
—
NCT00104273-outcome-0
NCT00104273
Cognitive Function
primary
—
—
NCT00104273-outcome-1
NCT00104273
Other Cognitive Assessments; Activities of Daily Living (ADLs); Functional Assessments; Safety; Tolerability.
secondary
—
—
NCT00104442-outcome-0
NCT00104442
Changes in specific brain enzyme activity from baseline to week 13
primary
—
—
NCT00104442-outcome-1
NCT00104442
Correlate changes in specific brain enzyme activity at week 13 to cognition and behavior
secondary
—
—
NCT00104442-outcome-2
NCT00104442
Changes in levels of protein biomarkers in Alzheimer's disease and neurodegeneration from baseline to week 13
secondary
—
—
NCT00104442-outcome-3
NCT00104442
Correlate changes in specific brain enzyme activity after 13 weeks treatment to changes in global functioning at 13 and 26 weeks
secondary
—
—
NCT00105547-outcome-0
NCT00105547
Cognition and activities of daily living
primary
—
18 mos
NCT00105547-outcome-1
NCT00105547
Global function and behavior
secondary
—
18 mos
NCT00105612-outcome-0
NCT00105612
MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR) to quantify decision making abilities
primary
—
—
NCT00105612-outcome-1
NCT00105612
Participant competency
secondary
—
—
NCT00105638-outcome-0
NCT00105638
Reduction in veteran agitation and symptoms of depression; increase in caregiver management skills
primary
—
—
NCT00105638-outcome-1
NCT00105638
Veterans will experience fewer hospitalizations and nursing home admissions
secondary
—
—
NCT00110552-outcome-0
NCT00110552
Cognitive function
primary
—
8 weeks
NCT00110552-outcome-1
NCT00110552
Stress
secondary
—
8 weeks
NCT00110552-outcome-2
NCT00110552
cognitive electrophysiology
secondary
—
8 weeks
NCT00112073-outcome-0
NCT00112073
safety assessments
primary
—
18 months
NCT00112073-outcome-1
NCT00112073
blood levels of administered study drug
secondary
—
18 months
NCT00112073-outcome-2
NCT00112073
cognitive and functional assessments
secondary
—
18 months
NCT00117403-outcome-0
NCT00117403
effect on cerebrospinal fluid (CSF) biomarkers related to oxidative damage
primary
—
baseline and 4 months
NCT00117403-outcome-1
NCT00117403
change in plasma and CSF concentrations of a-beta42 and a-beta40
secondary
—
baseline and 4 months
NCT00119561-outcome-0
NCT00119561
General well-being (revised Rand General Well-Being Scale); and caregiver's level of distress with care recipient behaviors (Revised Memory and Behavior Problems Checklist). Data is collected at baseline, 6 and 12 months in a face to face interview.