Trial · NCT00843518
Treatment for Aggression and Agitation in Patients With Alzheimer's Disease
NCT00843518, Phase 2, Completed, Eli Lilly and Company; results first posted 2017-11-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment for Aggression and Agitation in Patients With Alzheimer's Disease. Trials, record NCT00843518. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00843518
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment for Aggression and Agitation in Patients With Alzheimer's Disease
- NCT number
- NCT00843518
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 132 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Alzheimer's Disease
- Interventions
- LY451395, Placebo
- First posted
- 2009-02-13
- Last updated
- 2017-11-29
- Results first posted
- 2017-11-29
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in the 4-Item Agitation/Aggression Subscale of the Neuropsychiatric Inventory (NPI-4 A/A) at Week 12 | Baseline, Week 12 | NPI assessed noncognitive psychopathology in participants with Alzheimer's dementia. A 4-item subscale of the standard 12-item NPI measured the neuropsychiatric symptoms of A/A, with items consisting of agitation/aggression, aberrant motor behavior, irritability/emotional lability, and disinhibition. Scores for each subscale (frequency x severity) were calculated to obtain each item score. The total subscale score ranged from 0 to 48, with higher scores indicating more frequent and/or severe A/A symptoms. If a symptom was not present at all, the site would not enter anything for frequency or severity, and a zero would be imputed for that item. Least Squares (LS) Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline NPI-4 A/A, and baseline-by-visit interaction. |
| Secondary | Mean Change From Baseline in 10-Item Version of Neuropsychiatric Inventory (NPI-10) at Week 12 | Baseline, Week 12 | NPI assessed noncognitive psychopathology in participants with Alzheimer's dementia. A 10-item scale of the standard 12-item NPI measured neuropsychiatric symptoms minus the appetite and sleep disturbance items. Scores for each subscale (frequency × severity) were calculated to obtain the item score. The total subscale score ranged from 0 to 120, with higher scores indicating more frequent and/or severe A/A symptoms. If a symptom was not present at all, the site would not enter anything for frequency or severity, and a zero would be imputed for that item. LS Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline NPI-10, and baseline-by-visit interaction. |
| Secondary | Mean Change From Baseline in the Neuropsychiatric Inventory (NPI) Depression Domain at Week 12 | Baseline, Week 12 | NPI Depression domain was an item of the standard 12-item NPI that measured depression in participants with Alzheimer's dementia. Scores for each subscale (frequency × severity) were calculated to obtain the item score, which ranged from 0 to 12 with higher scores indicating more frequent and/or severe neuropsychiatric symptoms. If a symptom was not present at all, the site would not enter anything for frequency or severity, and a zero would be imputed for that item. LS Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline NPI depression, and baseline-by-visit interaction. |
| Secondary | Mean Change From Baseline in the Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 12 | Baseline, Week 12 | The NPI Psychosis subscale score was the sum of the delusions and hallucinations items of the standard 12-item NPI that measured psychosis symptoms in participants with Alzheimer's dementia. Scores for each subscale (frequency x severity) were calculated for each item score and ranged from 0 to 24 with higher scores indicating more frequent and/or severe neuropsychiatric symptoms. LS Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline NPI psychosis, and baseline-by-visit interaction. |
| Secondary | Mean Change From Baseline in Cohen-Mansfield Agitation Inventory-Community Version (CMAI-C) at Week 12 | Baseline, Week 12 | CMAI-C is the Cohen-Mansfield Agitation Inventory - Community Version, and it contained 36 questions. The first 35 items were rated from 1 (never) to 7 (several times per hour) and the last item asked if there was any other inappropriate behavior, with a free text field to specify the behavior. The total score ranged from 7 to 245 (7 x 35), with higher scores reflecting more severe agitation. LS Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline CMAI-C, and baseline-by-visit interaction. |
| Secondary | Mean Change From Baseline in Cornell Scale for Depression in Dementia (CSDD) at Week 12 | Baseline, Week 12 | CSDD was a 19-item, clinician-rated scale designed to measure the presence and severity of depressive symptoms in dementia participants. Symptoms were rated as absent, mild/intermittent, or severe. Scores ranged from 0 to 38; scores of 8 or more suggested clinical depression. LS Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline CSDD, and baseline-by-visit interaction. |
| Secondary | Mean Change From Baseline in Total T-Score in the Frontal System Behaviors Scale (FrSBe) at Week 12 | Baseline, Week 12 | FrSBe was a 46-item, caregiver-rated scale that assessed behaviors associated with damage to the frontal lobes and frontal systems of the brain, including executive function, disinhibition, and apathy. Raw scores were normalized to T-scores based on gender, education, and age. Higher T scores represent a worse outcome. A score of 50 reflects a normative sample, and T scores at or above 65 are considered clinically significant. LS Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline FrSBe, and baseline-by-visit interaction. |
| Secondary | Mean Change From Baseline in Clinical Global Impression-Severity-Agitation/Aggression (CGI-S-A/A) at Week 12 | Baseline, Week 12 | CGI-S-A/A was a 7-point, single-item rating scale for overall severity of symptoms based on the investigator's general clinical experience with a similar participant population. This Likert scale ranged from 0 (normal) to 7 (most severely ill). LS Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline CGI-S-A/A, and baseline-by-visit interaction. |
| Secondary | Mean Change From Baseline in Clinical Global Impression-Severity-Global Functioning (CGI-S-GF) at Week 12 | Baseline, Week 12 | CGI-S-GF was a 7-point, single-item rating scale for overall functioning based on the investigator's general clinical experience with a similar participant population. This Likert scale ranged from 0 (normal) to 7 (most severely ill). LS Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline CGI-S-GF, and baseline-by-visit interaction. |
| Secondary | Mean Change From Baseline in the 14-Item Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog14) at Week 12 | Baseline, Week 12 | ADAS-Cog14, a 14-item rating scale, measured the severity of cognitive dysfunction in persons with AD. Scores ranged from 0 to 90, with a higher score indicating worse cognitive functioning. LS Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline ADAS-Cog, and baseline-by-visit interaction. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in the 4-Item Agitation/Aggression Subscale of the Neuropsychiatric Inventory (NPI-4 A/A) at Week 12 | Baseline, Week 12 | The analysis population included all randomized participants and was a modified intent-to-treat (ITT) population defined as having both a baseline and at least 1 post-baseline measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in 10-Item Version of Neuropsychiatric Inventory (NPI-10) at Week 12 | Baseline, Week 12 | The analysis population included all randomized participants and was a modified intent-to-treat (ITT) population defined as having both a baseline and at least 1 post-baseline measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in the Neuropsychiatric Inventory (NPI) Depression Domain at Week 12 | Baseline, Week 12 | The analysis population included all randomized participants and was a modified intent-to-treat (ITT) population defined as having both a baseline and at least 1 post-baseline measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in the Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 12 | Baseline, Week 12 | The analysis population included all randomized participants and was a modified intent-to-treat (ITT) population defined as having both a baseline and at least 1 post-baseline measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Cohen-Mansfield Agitation Inventory-Community Version (CMAI-C) at Week 12 | Baseline, Week 12 | The analysis population included all randomized participants and was a modified intent-to-treat (ITT) population defined as having both a baseline and at least 1 post-baseline measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Cornell Scale for Depression in Dementia (CSDD) at Week 12 | Baseline, Week 12 | The analysis population included all randomized participants and was a modified intent-to-treat (ITT) population defined as having both a baseline and at least 1 post-baseline measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Total T-Score in the Frontal System Behaviors Scale (FrSBe) at Week 12 | Baseline, Week 12 | The analysis population included all randomized participants and was a modified intent-to-treat (ITT) population defined as having both a baseline and at least 1 post-baseline measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Clinical Global Impression-Severity-Agitation/Aggression (CGI-S-A/A) at Week 12 | Baseline, Week 12 | The analysis population included all randomized participants and was a modified intent-to-treat (ITT) population defined as having both a baseline and at least 1 post-baseline measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Clinical Global Impression-Severity-Global Functioning (CGI-S-GF) at Week 12 | Baseline, Week 12 | The analysis population included all randomized participants and was a modified intent-to-treat (ITT) population defined as having both a baseline and at least 1 post-baseline measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in the 14-Item Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog14) at Week 12 | Baseline, Week 12 | The analysis population included all randomized participants and was a modified intent-to-treat (ITT) population defined as having both a baseline and at least 1 post-baseline measure. | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in the 4-Item Agitation/Aggression Subscale of the Neuropsychiatric Inventory (NPI-4 A/A) at Week 12 | LY451395 | -5.4 | Standard Error 1.21 | units on a scale | |
| Mean Change From Baseline in the 4-Item Agitation/Aggression Subscale of the Neuropsychiatric Inventory (NPI-4 A/A) at Week 12 | Placebo | -6.2 | Standard Error 1.12 | units on a scale | |
| Mean Change From Baseline in 10-Item Version of Neuropsychiatric Inventory (NPI-10) at Week 12 | LY451395 | -8.2 | Standard Error 2.08 | units on a scale | |
| Mean Change From Baseline in 10-Item Version of Neuropsychiatric Inventory (NPI-10) at Week 12 | Placebo | -9.3 | Standard Error 1.93 | units on a scale | |
| Mean Change From Baseline in the Neuropsychiatric Inventory (NPI) Depression Domain at Week 12 | LY451395 | -0.2 | Standard Error 0.34 | units on a scale | |
| Mean Change From Baseline in the Neuropsychiatric Inventory (NPI) Depression Domain at Week 12 | Placebo | -1.0 | Standard Error 0.32 | units on a scale | |
| Mean Change From Baseline in the Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 12 | LY451395 | -0.4 | Standard Error 0.58 | units on a scale | |
| Mean Change From Baseline in the Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 12 | Placebo | -0.4 | Standard Error 0.54 | units on a scale | |
| Mean Change From Baseline in Cohen-Mansfield Agitation Inventory-Community Version (CMAI-C) at Week 12 | LY451395 | -7.2 | Standard Error 1.98 | units on a scale | |
| Mean Change From Baseline in Cohen-Mansfield Agitation Inventory-Community Version (CMAI-C) at Week 12 | Placebo | -4.1 | Standard Error 1.79 | units on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 2 (Double-blind Treatment) | STARTED | LY451395 | 63 | |
| Period 2 (Double-blind Treatment) | STARTED | Placebo | 69 | |
| Period 2 (Double-blind Treatment) | COMPLETED | LY451395 | 43 | |
| Period 2 (Double-blind Treatment) | COMPLETED | Placebo | 49 | |
| Period 2 (Double-blind Treatment) | NOT COMPLETED | LY451395 | 20 | |
| Period 2 (Double-blind Treatment) | NOT COMPLETED | Placebo | 20 | |
| Period 3 (Single-blind Washout) | STARTED | LY451395 | 42 | |
| Period 3 (Single-blind Washout) | STARTED | Placebo | 49 | |
| Period 3 (Single-blind Washout) | COMPLETED | LY451395 | 42 | |
| Period 3 (Single-blind Washout) | COMPLETED | Placebo | 49 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events216
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | LY451395 Acute Treatment | 2 | 63 | 2 |
| other | Constipation | Gastrointestinal disorders | Placebo Acute Treatment | 2 | 69 | 2 |
| other | Constipation | Gastrointestinal disorders | LY451395 Washout | 0 | 42 | 0 |
| other | Constipation | Gastrointestinal disorders | Placebo Washout | 0 | 49 | 0 |
| other | Constipation | Gastrointestinal disorders | LY451395 Post-Study | 0 | 63 | 0 |
| other | Constipation | Gastrointestinal disorders | Placebo Post-Study | 0 | 69 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | LY451395 Acute Treatment | 3 | 63 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Acute Treatment | 3 | 69 | 6 |
| other | Diarrhoea | Gastrointestinal disorders | LY451395 Washout | 0 | 42 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Washout | 0 | 49 | 0 |
1 to 10 of 216Source ClinicalTrials.gov
See all 216 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LY451395 Acute Treatment | ||
| Total, all-cause mortality | Placebo Acute Treatment | ||
| Total, all-cause mortality | LY451395 Washout | ||
| Total, all-cause mortality | Placebo Washout | ||
| Total, all-cause mortality | LY451395 Post-Study | ||
| Total, all-cause mortality | Placebo Post-Study | ||
| Total, other adverse events | LY451395 Acute Treatment | 24 | 63 |
| Total, other adverse events | Placebo Acute Treatment | 24 | 69 |
| Total, other adverse events | LY451395 Washout | 1 | 42 |
| Total, other adverse events | Placebo Washout | 2 | 49 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23257314 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00843518
GET https://conductscience.org/api/trials/v1/NCT00843518/events?page=2