Trial Outcomes & Findings for Study of Memantine to Treat Huntington's Disease (NCT NCT00652457)

Results Overview

The HVLT-R consists of 3 parts. Free recall has a range of 0 to 36, delayed recall has a range from 0 to 12, and delayed recognition has a range of -12 to 12. Higher scores indicating better function in all 3 parts. Standardized scores are used by calculating an average standardized z score for each part of the HVLT-R. Change is calculated by subtracting baseline value from the respective later time point value. Imputation methods were used to determine values for all alive patients missing the post-baseline assessments. This tool is being used to measure cognitive function, specifically memory.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

Baseline, 3 months from start of drug treatment, 6 months from start of drug treatment

Results posted on

2021-01-05

Participant Flow

Sixty-five participants were screened for eligibility; 6 individuals failed screening by not meeting inclusion criteria forthe study; 9 declined to participate. Fifty participants were then randomized.

Participant milestones

Participant milestones
Measure	Memantine, Then Memantine Participants first received 10 mg Memantine twice a day for 3 months. No washout. Participants continued on 10 mg Memantine twice a day for another 3 months.	Placebo, Then Memantine Participants first received Placebo twice a day for 3 months. No washout. Participants then received 10 mg Memantine twice a day for 3 months.
Overall Study STARTED	23	27
Overall Study COMPLETED	23	27
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Memantine to Treat Huntington's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=50 Participants Total of all reporting groups due to age of study. Data was not analyzed per arm.
Age, Continuous	47.3 years STANDARD_DEVIATION NA • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3 months from start of drug treatment, 6 months from start of drug treatment

Population: Due to the age of this study (2003), the data is no longer accessible. We have been moved a number of times in 17 years and that data has been lost.

The HVLT-R consists of 3 parts. Free recall has a range of 0 to 36, delayed recall has a range from 0 to 12, and delayed recognition has a range of -12 to 12. Higher scores indicating better function in all 3 parts. Standardized scores are used by calculating an average standardized z score for each part of the HVLT-R. Change is calculated by subtracting baseline value from the respective later time point value. Imputation methods were used to determine values for all alive patients missing the post-baseline assessments. This tool is being used to measure cognitive function, specifically memory.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 3 months from start of drug treatment, 6 months from start of drug treatment

Population: Due to the age of this study (2003), the data is no longer accessible. We have been moved a number of times in 17 years and that data has been lost.

The Neuropsychiatric Inventory (NPI) assesses the frequency and severity of 12 common behavioral symptoms in dementia. The NPI Score is calculated by multiplying the total reported frequency by the severity score, with a theoretical range of 0-1704: high scores indicating greater frequency by severity. The change between 2 or more time points is being reported.

Outcome measures

Outcome data not reported

Adverse Events

Memantine, Then Memantine

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo, Then Memantine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Memantine, Then Memantine n=23 participants at risk Participants first received 10 mg Memantine twice a day for 3 months. No washout. Participants continued on 10 mg Memantine twice a day for another 3 months.	Placebo, Then Memantine n=27 participants at risk Participants first received Placebo twice a day for 3 months. No washout. Participants then received 10 mg Memantine twice a day for 3 months.
Nervous system disorders Dizziness	8.7% 2/23 • Number of events 2 • 6 months Due to the age of this study (2003), the data regarding individual arms is no longer accessible. We have been moved a number of times in 17 years and that data has been lost.	3.7% 1/27 • Number of events 1 • 6 months Due to the age of this study (2003), the data regarding individual arms is no longer accessible. We have been moved a number of times in 17 years and that data has been lost.
Gastrointestinal disorders Diarrhea	8.7% 2/23 • Number of events 2 • 6 months Due to the age of this study (2003), the data regarding individual arms is no longer accessible. We have been moved a number of times in 17 years and that data has been lost.	0.00% 0/27 • 6 months Due to the age of this study (2003), the data regarding individual arms is no longer accessible. We have been moved a number of times in 17 years and that data has been lost.

Additional Information

Jody Corey-Bloom, MD, PhD

University of California, San Diego

Phone: 858-249-0574

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place