Trial Outcomes & Findings for Comparison of Once Daily and Twice Daily Dosing on Safety and Tolerability of Memantine in Patients With Alzheimer (NCT NCT02553928)

Results Overview

Number of patients who reported adverse events

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

62 participants

Primary outcome timeframe

baseline to week 16 (end of study)

Results posted on

2019-03-14

Participant Flow

Participant milestones

Participant milestones
Measure	Memantine (Once Daily) Memantine 20 mg once daily, tablets, orally AND Placebo tablets once daily, orally	Memantine (Twice Daily) Memantine 10 mg twice daily, tablets, orally AND Placebo tablets twice daily, orally
Overall Study STARTED	30	32
Overall Study COMPLETED	28	29
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Memantine (Once Daily) Memantine 20 mg once daily, tablets, orally AND Placebo tablets once daily, orally	Memantine (Twice Daily) Memantine 10 mg twice daily, tablets, orally AND Placebo tablets twice daily, orally
Overall Study Adverse Event	2	1
Overall Study Lost to Follow-up	0	1
Overall Study Administrative reason(s)	0	1

Baseline Characteristics

Comparison of Once Daily and Twice Daily Dosing on Safety and Tolerability of Memantine in Patients With Alzheimer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Memantine (Once Daily) n=30 Participants Memantine 20 mg once daily, tablets, orally AND Placebo tablets once daily, orally	Memantine (Twice Daily) n=32 Participants 10 mg given twice daily, tablets, orally AND Placebo tablets twice daily, orally	Total n=62 Participants Total of all reporting groups
Age, Continuous	69.1 years STANDARD_DEVIATION 9.3 • n=5 Participants	70.3 years STANDARD_DEVIATION 8.1 • n=7 Participants	69.7 years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized Asian	30 Participants n=5 Participants	32 Participants n=7 Participants	62 Participants n=5 Participants
MMSE Total Score	11.4 units on a scale STANDARD_DEVIATION 4.2 • n=5 Participants	11.4 units on a scale STANDARD_DEVIATION 4.5 • n=7 Participants	11.4 units on a scale STANDARD_DEVIATION 4.3 • n=5 Participants
Modified Hachinski Ischemia Total Score	1.6 units on a scale STANDARD_DEVIATION 1.2 • n=5 Participants	1.8 units on a scale STANDARD_DEVIATION 0.9 • n=7 Participants	1.7 units on a scale STANDARD_DEVIATION 1.0 • n=5 Participants
Duration of Alzheimer's Disease	2.1 years STANDARD_DEVIATION 1.9 • n=5 Participants	2.3 years STANDARD_DEVIATION 1.9 • n=7 Participants	2.2 years STANDARD_DEVIATION 1.9 • n=5 Participants

PRIMARY outcome

Timeframe: baseline to week 16 (end of study)

Population: All patients treated

Number of patients who reported adverse events

Outcome measures

Outcome measures
Measure	Memantine (Once Daily) n=30 Participants Memantine 20 mg once daily, tablets, orally AND Placebo tablets once daily, orally	Memantine (Twice Daily) n=32 Participants Memantine 10 mg twice daily, tablets, orally AND Placebo tablets twice daily, orally
Adverse Events	15 Participants	16 Participants

SECONDARY outcome

Timeframe: ADCS - CGIC score at Week 12

Population: Full analysis set - all randomised patients who took at least one dose of investigational medicinal product, and who had a valid baseline assessment and at least one valid post-baseline assessment of the ADCS-CGIC.

The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) is a semi-structured interview designed to assess clinically relevant changes in patients with Alzheimer's disease. Items in the ADCS-CGIC interview provide general information, and information about cognition, behaviour, social and daily functioning. Responses to ADCS-CGIC interview result in a global clinical judgement of severity (at baseline) and clinically relevant change at subsequent visits. Severity rated at baseline is only used for reference. The severity at baseline is rated on a 7-point Likert-type scale from 1(normal, not ill at all) to 7 (among the most extremely ill patients). The ADCS-CGIC relevant change is rated on a 7-point Likert-type scale from 1 (marked improvement) to 7 (marked worsening).

Outcome measures

Outcome measures
Measure	Memantine (Once Daily) n=29 Participants Memantine 20 mg once daily, tablets, orally AND Placebo tablets once daily, orally	Memantine (Twice Daily) n=29 Participants Memantine 10 mg twice daily, tablets, orally AND Placebo tablets twice daily, orally
ADCS - CGIC Score at Week 12	3.92 units on a scale Standard Error 0.14	3.60 units on a scale Standard Error 0.14

Adverse Events

Memantine (Once Daily)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Memantine (Twice Daily)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Memantine (Once Daily) n=30 participants at risk Memantine 20 mg once daily, tablets, orally AND Placebo tablets once daily, orally	Memantine (Twice Daily) n=32 participants at risk Memantine 10 mg twice daily, tablets, orally AND Placebo tablets twice daily, orally
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/30 • Baseline to week 16 (end of study)	3.1% 1/32 • Number of events 1 • Baseline to week 16 (end of study)

Other adverse events

Other adverse events
Measure	Memantine (Once Daily) n=30 participants at risk Memantine 20 mg once daily, tablets, orally AND Placebo tablets once daily, orally	Memantine (Twice Daily) n=32 participants at risk Memantine 10 mg twice daily, tablets, orally AND Placebo tablets twice daily, orally
Cardiac disorders Sinus bradycardia	6.7% 2/30 • Number of events 2 • Baseline to week 16 (end of study)	0.00% 0/32 • Baseline to week 16 (end of study)
Investigations White blood cell count decreased	6.7% 2/30 • Number of events 2 • Baseline to week 16 (end of study)	0.00% 0/32 • Baseline to week 16 (end of study)
Renal and urinary disorders Urinary incontinence	0.00% 0/30 • Baseline to week 16 (end of study)	6.2% 2/32 • Number of events 2 • Baseline to week 16 (end of study)
Vascular disorders Hypertension	6.7% 2/30 • Number of events 2 • Baseline to week 16 (end of study)	0.00% 0/32 • Baseline to week 16 (end of study)

Additional Information

H. Lundbeck

H. Lundbeck A/S

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place