Trial Outcomes & Findings for An Extension To The B1451006 Protocol To Evaluate The Safety and Efficacy of Dimebon In Subjects With Moderate-to-Severe Alzheimer's Disease (NCT NCT01066546)
NCT ID: NCT01066546
Last Updated: 2012-10-02
Results Overview
An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
TERMINATED
PHASE3
5 participants
Baseline up to 4 weeks after last dose of study treatment
2012-10-02
Participant Flow
Participant milestones
| Measure |
Dimebon
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Dimebon
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
|
|---|---|
|
Overall Study
Study terminated by sponsor
|
5
|
Baseline Characteristics
An Extension To The B1451006 Protocol To Evaluate The Safety and Efficacy of Dimebon In Subjects With Moderate-to-Severe Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Dimebon
n=5 Participants
Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
|
|---|---|
|
Age, Customized
Less than 50 years
|
0 participants
n=5 Participants
|
|
Age, Customized
50 to 59 years
|
1 participants
n=5 Participants
|
|
Age, Customized
60 to 69 years
|
0 participants
n=5 Participants
|
|
Age, Customized
70 to 79 years
|
1 participants
n=5 Participants
|
|
Age, Customized
80 to 85 years
|
2 participants
n=5 Participants
|
|
Age, Customized
Greater than 85 years
|
1 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 4 weeks after last dose of study treatmentPopulation: Safety analysis population included all enrolled participants who received at least 1 dose of study treatment, including partial doses.
An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Outcome measures
| Measure |
Dimebon
n=5 Participants
Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
|
|---|---|
|
Number of Participants With Adverse Events (AEs)
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 6, 12, 26Population: Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.
SIB developed for evaluation of cognitive function in participants, who demented to a degree that they cannot complete conventional neuropsychological testing. Test items consisted of simple, one-step commands presented with gestural cues and instructions that were repeated if necessary. SIB test consisted of 51-item scale, divided into 9 subscales: social interaction (0-6), memory (0-14), orientation (0-6), language (0-46), attention (0-6), praxis (0-8), visuospatial ability (0-8), construction(0-4), orienting to name(0-2). Total possible score:0-100; lower score=greater cognitive impairment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 6, 12, 26Population: Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.
ADCS-ADLsev: 19-item scale measures basic and instrumental abilities in participant population and had good metric properties and reliability in detecting change. Individual score range: 0 to 5 for telephone, 0 to 4 for dressing, watch television, get around outside home, 0 to 3 for eating, walking, toilet, bathing, grooming, conversation/small talk, clear dishes, find personal belongings, obtain beverages, dispose of garbage, left on own, 0 to 1 for run water from and turn off faucet to wash hands, turn on and off light. Total score range: 0 to 54 lower scores=greater functional impairment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12, 26Population: Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.
MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; ranged from 0 to 30, higher score indicates better cognitive state.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 6, 12, 26Population: Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.
NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity(1=Mild to 3=Severe),frequency(1=occasionally to 4=very frequently) scales recorded for each domain; frequency\*severity=each domain score(range 0-12). Total score=sum of each domain score(range 0-144);higher score=greater behavioral disturbances;negative change score from baseline=improvement.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 26Population: Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.
NPI is a 12-domain caregiver assessment of behavioral disturbances occurring in dementia. Severity (1=Mild to 3=Severe) and frequency (1=occasionally to 4=very frequently) scales were recorded separately for each domain and their product gives individual domain score (range 0-12). Sum of delusions and hallucinations sub-domain scores of NPI was calculated as a measure of Alzheimer's Disease (AD) related psychosis. Total possible score range: 0-24 with higher score indicating greater behavioral disturbances.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12, 26Population: Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.
RUD Lite: instrument used to assess amount of both formal and informal resources used by demented participants and primary caregiver. It was completed by caregivers and compiles data on following resources: use of social services, frequency and duration of hospitalizations, all contacts with health care professionals, participant living accommodations, amount of time the caregiver spends giving care and the impact of care giving on the caregiver's job. Overall cost of care was evaluated to quantify the resources utilized.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12, 26Population: Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Total possible score is sum of individual items, ranged from 5 to 15; lower score indicated a better health state.
Outcome measures
Outcome data not reported
Adverse Events
Dimebon
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dimebon
n=5 participants at risk
Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER