Trial · NCT02129348
Treatment of Psychosis and Agitation in Alzheimer's Disease
NCT02129348, Phase 2, Completed, New York State Psychiatric Institute; results first posted 2021-08-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment of Psychosis and Agitation in Alzheimer's Disease. Trials, record NCT02129348. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02129348
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Psychosis and Agitation in Alzheimer's Disease
- NCT number
- NCT02129348
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 77 participants, actual
- Lead sponsor
- New York State Psychiatric Institute
- Conditions
- Alzheimer's Disease, Psychosis, Agitation
- Interventions
- Lithium, Placebo
- First posted
- 2014-05-02
- Last updated
- 2024-05-02
- Results first posted
- 2021-08-16
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score | Assessed at screening, Week 0, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 | Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain is the measure used that combines symptoms of agitation and aggression. Frequency X Severity rating score, range 0-12. Minimum score is 0, maximum score is 12. Higher score is a worse outcome and indicates more agitation and aggressive behavior. |
| Secondary | Clinical Responder Defined as a 30% Decrease in NPI Core Score (Sum Score of NPI Domains of Agitation/Aggression, Delusions and Hallucinations) Together With a Clinical Global Impression (CGI) Behavior Change Score of 1 or 2 | Week 12 | The patient is classified as a responder (score=1) if both criteria are met or as a non-responder (score=0) if both criteria are not met. The first criterion to determine responder status, NPI core score, has a scoring range 0-36; each of the three component scores for symptoms of agitation/aggression, delusions and hallucinations has a scoring range 0-12. For each symptom and the total score, higher score indicates more symptoms. The second criterion to determine responder status, Clinical Global Impression (CGI), is used to assess change in overall behavior; scoring range 1-7 with higher scores indicating worsening over time and lower scores indicating improvement over time. Only patients who met both criteria, assessed as change compared to baseline, were counted as responders; all other patients were non-responders. Patients that demonstrated improvement at week 12 were reported; scores for earlier weeks were only used to assess progress throughout the study. |
| Secondary | Clinical Global Impression (CGI) Behavior Change | Week 12 | Clinical Global Impression (CGI) Behavior Change score is the measure used to assess change in overall behavior; scoring range 1-7 with higher scores indicating worsening over time and lower scores indicating improvement over time. Scores ranging from 1-3 indicate improvement. Only patients that demonstrated improvement at week 12 were reported; scores for earlier weeks were only used to assess progress throughout the study. |
| Secondary | Young Mania Rating Scale | Assessed at Week 0, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 | Young Mania Rating Scale total score is the measure used to assess symptoms that occur in mania; each item is a symptom that is rated for severity. Scoring range 0-60. Minimum score is 0 and maximum score is 60. Higher scores mean a worse outcome. |
| Secondary | Treatment Emergent Signs and Symptoms | Assessed at Week 0, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 | Treatment Emergent Symptom Scale that covers 26 somatic symptoms, each rated as present (score=1) or absent (score=0). Total score is the measure used with scoring range 0-26; higher scores indicate more somatic symptoms. |
| Secondary | Simpson-Angus Scale | Assessed at Week 0, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 | Simpson Angus Scale for Extrapyramidal Sign requires in-person examination to assess gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella tap, tremor, and salivation. Total score is the measure used, range 0-40; higher scores indicate increased severity of signs. |
| Secondary | Basic Activities of Daily Living (BADL) | Assessed at Week 0, Week2, Week 4, Week 6, Week 8, Week 10, Week 12 | Basic Activities of Daily Living with items for 6 functions: bathing, dressing, toileting, transferring, continence, and feeding. Each item is scored as unimpaired=1, impaired=0. Total score is the measure used, range 0-6; higher scores indicate better functioning. |
| Secondary | Zarit Caregiver Burden Interview | Assessed at Week 0, Week 4, Week 8, Week 10, Week 12 | Zarit Caregiver Burden Interview with the caregiver asked to rank 22 items on a scale with responses for each item from 'never' (score 0) to 'nearly always' (score 4). Total score is the measure used; range 0-88 with higher scores indicating greater caregiver burden. |
| Other | Folstein Mini-Mental Status Exam | Assessed at Screening, Week 12 | 30 item questionnaire used to assess degree of cognitive impairment. Orientation, registration, attention/calculation, recall, language, repetitions and commands are assessed. Total score is the measure used; range 0-30, higher scores indicate better global cognitive function. |
| Other | Severe Impairment Battery | Assessed at Week 0, Week 12 | Neuropsychological test used to assess a patient's cognitive ability. The patient is asked to complete small tasks such as drawing shapes and printing their name. They are also asked to remember certain names and objects, such as a cup and a spoon, and the evaluator's first name. Total score is the measure used; range 0-100, higher scores indicate better cognition. |
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 | Change in Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score | Assessed at screening, Week 0, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Clinical Responder Defined as a 30% Decrease in NPI Core Score (Sum Score of NPI Domains of Agitation/Aggression, Delusions and Hallucinations) Together With a Clinical Global Impression (CGI) Behavior Change Score of 1 or 2 | Week 12 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Clinical Global Impression (CGI) Behavior Change | Week 12 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Young Mania Rating Scale | Assessed at Week 0, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Treatment Emergent Signs and Symptoms | Assessed at Week 0, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Simpson-Angus Scale | Assessed at Week 0, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Basic Activities of Daily Living (BADL) | Assessed at Week 0, Week2, Week 4, Week 6, Week 8, Week 10, Week 12 | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Zarit Caregiver Burden Interview | Assessed at Week 0, Week 4, Week 8, Week 10, Week 12 | score on a scale | LEAST_SQUARES_MEAN | |
| OTHER_PRE_SPECIFIED | Folstein Mini-Mental Status Exam | Assessed at Screening, Week 12 | score on a scale | LEAST_SQUARES_MEAN | |
| OTHER_PRE_SPECIFIED | Severe Impairment Battery | Assessed at Week 0, Week 12 | score 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 |
|---|---|---|---|---|---|
| Change in Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score | Lithium Treatment Group | 3.2 | 95% Confidence Interval 1.7 to 4.6 | score on a scale | |
| Change in Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score | Placebo Group | 2.5 | 95% Confidence Interval 1.1 to 4.0 | score on a scale | |
Clinical Responder Defined as a 30% Decrease in NPI Core Score (Sum Score of NPI Domains of Agitation/Aggression, Delusions and Hallucinations) Together With a Clinical Global Impression (CGI) Behavior Change Score of 1 or 2 | Lithium Treatment Group | 12 | Participants | ||
Clinical Responder Defined as a 30% Decrease in NPI Core Score (Sum Score of NPI Domains of Agitation/Aggression, Delusions and Hallucinations) Together With a Clinical Global Impression (CGI) Behavior Change Score of 1 or 2 | Placebo Group | 7 | Participants | ||
| Clinical Global Impression (CGI) Behavior Change | Lithium Treatment Group | 12 | Participants | ||
| Clinical Global Impression (CGI) Behavior Change | Placebo Group | 8 | Participants | ||
| Young Mania Rating Scale | Lithium Treatment Group | 3.1 | 95% Confidence Interval 0.9 to 5.3 | score on a scale | |
| Young Mania Rating Scale | Placebo Group | 1.1 | 95% Confidence Interval -1.1 to 3.3 | score on a scale | |
| Treatment Emergent Signs and Symptoms | Lithium Treatment Group | 0.6 | 95% Confidence Interval -1.3 to 2.4 | score on a scale | |
| Treatment Emergent Signs and Symptoms | Placebo Group | 0.7 | 95% Confidence Interval -1.1 to 2.5 | score on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lithium Treatment Group | 38 | |
| Overall Study | STARTED | Placebo Group | 39 | |
| Overall Study | COMPLETED | Lithium Treatment Group | 29 | |
| Overall Study | COMPLETED | Placebo Group | 29 | |
| Overall Study | NOT COMPLETED | Lithium Treatment Group | 9 | |
| Overall Study | NOT COMPLETED | Placebo Group | 10 |
Source ClinicalTrials.gov
Adverse events60
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 | Increased Agitation | Psychiatric disorders | Lithium Treatment Group | 6 | 38 | 6 |
| other | Increased Agitation | Psychiatric disorders | Placebo Group | 11 | 39 | 11 |
| other | Fall | Musculoskeletal and connective tissue disorders | Lithium Treatment Group | 7 | 38 | 7 |
| other | Fall | Musculoskeletal and connective tissue disorders | Placebo Group | 3 | 39 | 3 |
| other | Diarrhea | Gastrointestinal disorders | Lithium Treatment Group | 3 | 38 | 3 |
| other | Diarrhea | Gastrointestinal disorders | Placebo Group | 4 | 39 | 4 |
| other | Reduced Kidney Function | Renal and urinary disorders | Lithium Treatment Group | 3 | 38 | 3 |
| other | Reduced Kidney Function | Renal and urinary disorders | Placebo Group | 2 | 39 | 2 |
| other | Vomiting | Gastrointestinal disorders | Lithium Treatment Group | 4 | 38 | 4 |
| other | Vomiting | Gastrointestinal disorders | Placebo Group | 1 | 39 | 1 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lithium Treatment Group | 0 | 38 |
| Total, all-cause mortality | Placebo Group | 0 | 39 |
| Total, other adverse events | Lithium Treatment Group | 30 | 38 |
| Total, other adverse events | Placebo Group | 33 | 39 |
| Total, serious adverse events | Lithium Treatment Group | 11 | 38 |
| Total, serious adverse events | Placebo Group | 11 | 39 |
Source ClinicalTrials.gov
Papers25
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01AG047146 | Treatment of psychosis and agitation in Alzheimers disease | DEVANAND, DAVANGERE P | NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC | NATIONAL INSTITUTE ON AGING | 2014 to 2018 |
Source NIH RePORTER
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lithium Treatment Group vs Placebo Group: Clinical Global Impression (CGI) Behavior Change | Trial comparisons |
Lithium Treatment Group vs Placebo Group: Clinical Responder Defined as a 30% Decrease in NPI Core Score (Sum Score of NPI Domains of Agitation/Aggression, Delusions and Hallucinations) Together With a Clinical Global Impression (CGI) Behavior Change Score of 1 or 2 | Trial comparisons |
| Lithium Treatment Group vs Placebo Group: deaths from any cause | Trial comparisons |
| Lithium Treatment Group vs Placebo Group: serious adverse events | Trial comparisons |
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/NCT02129348
GET https://conductscience.org/api/trials/v1/NCT02129348/events?page=2