Trial Outcomes & Findings for Anti-viral Therapy in Alzheimer's Disease (NCT NCT03282916)
NCT ID: NCT03282916
Last Updated: 2025-09-25
Results Overview
The modified ADAS-COG11 is a neuropsychological test used to measure the severity of cognitive dysfunction in Alzheimer's disease. The full range is 0 to 70, where a higher score indicates worse cognition.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
Baseline, Week 78
Results posted on
2025-09-25
Participant Flow
Recruitment occurred in 3 U.S. academic sites: Columbia University, New York University, and Banner Health.
Participant milestones
| Measure |
Valacyclovir
60 participants were assigned to receive valacyclovir for 78 weeks. Oral valacyclovir was distributed in 500 mg caplets. Participants took 8 caplets per day, 4 caplets in the morning and 4 caplets in the evening.
|
Placebo
60 participants were assigned to receive placebo for 78 weeks. The oral placebo (sugar pill) was matched in appearance to valacyclovir and distributed in 500 mg caplets. Participants took 8 caplets per day divided into 4 caplets in the morning and 4 caplets in the evening.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
44
|
47
|
|
Overall Study
NOT COMPLETED
|
16
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anti-viral Therapy in Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Valacyclovir
n=60 Participants
The oral valacyclovir will be distributed in 500mg caplets. Patients will take 8 caplets per day.
Valacyclovir: Valacyclovir hydrochloride 500mg caplet
|
Placebo
n=60 Participants
The oral placebo (sugar pill) will be distributed in 500mg caplets. Patients will take 8 caplets per day.
Placebo: Placebo sugar pill 500mg caplet
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.3 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
71.6 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
71.5 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White non-Hispanic
|
44 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black non-Hispanic
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
60 participants
n=7 Participants
|
120 participants
n=5 Participants
|
|
ADAS-Cog11
|
20.6 units on a scale
STANDARD_DEVIATION 6.6 • n=5 Participants
|
19.2 units on a scale
STANDARD_DEVIATION 7.6 • n=7 Participants
|
19.9 units on a scale
STANDARD_DEVIATION 7.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 78The modified ADAS-COG11 is a neuropsychological test used to measure the severity of cognitive dysfunction in Alzheimer's disease. The full range is 0 to 70, where a higher score indicates worse cognition.
Outcome measures
| Measure |
Valacyclovir
n=60 Participants
60 participants were assigned to receive valacyclovir for 78 weeks. Oral valacyclovir was distributed in 500 mg caplets. Participants took 8 caplets per day, 4 caplets in the morning and 4 caplets in the evening.
|
Placebo
n=60 Participants
60 participants were assigned to receive placebo for 78 weeks. The oral placebo (sugar pill) was matched in appearance to valacyclovir and distributed in 500 mg caplets. Participants took 8 caplets per day divided into 4 caplets in the morning and 4 caplets in the evening.
|
|---|---|---|
|
Alzheimer's Disease Assessment Scale - Cognition (ADAS-COG11, Modified Version) Score
Baseline
|
20.6 score on a scale
Standard Deviation 6.6
|
19.2 score on a scale
Standard Deviation 7.6
|
|
Alzheimer's Disease Assessment Scale - Cognition (ADAS-COG11, Modified Version) Score
78 weeks
|
30.2 score on a scale
Standard Deviation 13.9
|
25.3 score on a scale
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: Baseline, Week 78ADCS-ADL is a caregiver-reported scale to assess a patient's ability to perform everyday tasks. The full score range 0 to 78, with higher scores indicating better functioning.
Outcome measures
| Measure |
Valacyclovir
n=60 Participants
60 participants were assigned to receive valacyclovir for 78 weeks. Oral valacyclovir was distributed in 500 mg caplets. Participants took 8 caplets per day, 4 caplets in the morning and 4 caplets in the evening.
|
Placebo
n=60 Participants
60 participants were assigned to receive placebo for 78 weeks. The oral placebo (sugar pill) was matched in appearance to valacyclovir and distributed in 500 mg caplets. Participants took 8 caplets per day divided into 4 caplets in the morning and 4 caplets in the evening.
|
|---|---|---|
|
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score
Baseline
|
65.8 score on a scale
Standard Deviation 10.5
|
65.6 score on a scale
Standard Deviation 11.4
|
|
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score
Week 78
|
52.4 score on a scale
Standard Deviation 20.9
|
54.3 score on a scale
Standard Deviation 19.8
|
SECONDARY outcome
Timeframe: Baseline, Week 7818F-Florbetapir PET imaging will show amyloid accumulation in a sum of six ROIs (Region of Interest) (cerebellar reference) that show increased uptake in AD: medial orbital frontal, anterior cingulate, parietal, temporal, posterior cingulate, precuneus. The full range is approximately 0 to 4 SUVR (Standardized Uptake Value Ratio), with higher SUVR indicating more amyloid.
Outcome measures
| Measure |
Valacyclovir
n=60 Participants
60 participants were assigned to receive valacyclovir for 78 weeks. Oral valacyclovir was distributed in 500 mg caplets. Participants took 8 caplets per day, 4 caplets in the morning and 4 caplets in the evening.
|
Placebo
n=60 Participants
60 participants were assigned to receive placebo for 78 weeks. The oral placebo (sugar pill) was matched in appearance to valacyclovir and distributed in 500 mg caplets. Participants took 8 caplets per day divided into 4 caplets in the morning and 4 caplets in the evening.
|
|---|---|---|
|
Total 18F-Florbetapir Brain Uptake
Baseline
|
1.57 SUVR
Standard Deviation 0.37
|
1.57 SUVR
Standard Deviation 0.41
|
|
Total 18F-Florbetapir Brain Uptake
Week 78
|
1.63 SUVR
Standard Deviation 0.35
|
1.60 SUVR
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: Baseline, Week 78Population: MK-6240 PET imaging was funded by a grant supplement after the study began and therefore the number of participants for this component was less than the total sample.
18F-MK-6240 tau PET imaging will show tau accumulation, SUVR: average of medial temporal regions (amygdala, hippocampus, entorhinal, parahippocampus) with cerebellar reference. The full range is approximately 0 to 5 SUVR, with higher SUVR indicating more tau accumulation.
Outcome measures
| Measure |
Valacyclovir
n=47 Participants
60 participants were assigned to receive valacyclovir for 78 weeks. Oral valacyclovir was distributed in 500 mg caplets. Participants took 8 caplets per day, 4 caplets in the morning and 4 caplets in the evening.
|
Placebo
n=49 Participants
60 participants were assigned to receive placebo for 78 weeks. The oral placebo (sugar pill) was matched in appearance to valacyclovir and distributed in 500 mg caplets. Participants took 8 caplets per day divided into 4 caplets in the morning and 4 caplets in the evening.
|
|---|---|---|
|
Total 18F-MK-6240 Temporal Lobe Brain Uptake
Baseline
|
2.18 SUVR
Standard Deviation 0.82
|
1.91 SUVR
Standard Deviation 0.88
|
|
Total 18F-MK-6240 Temporal Lobe Brain Uptake
Week 78
|
2.32 SUVR
Standard Deviation 0.79
|
1.90 SUVR
Standard Deviation 0.89
|
Adverse Events
Valacyclovir
Serious events: 14 serious events
Other events: 11 other events
Deaths: 2 deaths
Placebo
Serious events: 11 serious events
Other events: 8 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Valacyclovir
n=60 participants at risk
The oral valacyclovir will be distributed in 500mg caplets. Patients will take 8 caplets per day.
Valacyclovir: Valacyclovir hydrochloride 500mg caplet
|
Placebo
n=60 participants at risk
The oral placebo (sugar pill) will be distributed in 500mg caplets. Patients will take 8 caplets per day.
Placebo: Placebo sugar pill 500mg caplet
|
|---|---|---|
|
Nervous system disorders
Seizure, confusion
|
3.3%
2/60 • Number of events 2 • 78 weeks
Adverse events information was reported by the participant or informant without a specific scale being administered.
|
0.00%
0/60 • 78 weeks
Adverse events information was reported by the participant or informant without a specific scale being administered.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress, pneumonia
|
6.7%
4/60 • Number of events 5 • 78 weeks
Adverse events information was reported by the participant or informant without a specific scale being administered.
|
6.7%
4/60 • Number of events 5 • 78 weeks
Adverse events information was reported by the participant or informant without a specific scale being administered.
|
|
Musculoskeletal and connective tissue disorders
Falls
|
1.7%
1/60 • Number of events 1 • 78 weeks
Adverse events information was reported by the participant or informant without a specific scale being administered.
|
3.3%
2/60 • Number of events 2 • 78 weeks
Adverse events information was reported by the participant or informant without a specific scale being administered.
|
|
Renal and urinary disorders
Kidney failure
|
5.0%
3/60 • Number of events 3 • 78 weeks
Adverse events information was reported by the participant or informant without a specific scale being administered.
|
1.7%
1/60 • Number of events 1 • 78 weeks
Adverse events information was reported by the participant or informant without a specific scale being administered.
|
|
Cardiac disorders
Cardiac
|
5.0%
3/60 • Number of events 3 • 78 weeks
Adverse events information was reported by the participant or informant without a specific scale being administered.
|
5.0%
3/60 • Number of events 3 • 78 weeks
Adverse events information was reported by the participant or informant without a specific scale being administered.
|
|
Gastrointestinal disorders
nausea, abdominal pain, diarrhea
|
1.7%
1/60 • Number of events 1 • 78 weeks
Adverse events information was reported by the participant or informant without a specific scale being administered.
|
1.7%
1/60 • Number of events 1 • 78 weeks
Adverse events information was reported by the participant or informant without a specific scale being administered.
|
Other adverse events
| Measure |
Valacyclovir
n=60 participants at risk
The oral valacyclovir will be distributed in 500mg caplets. Patients will take 8 caplets per day.
Valacyclovir: Valacyclovir hydrochloride 500mg caplet
|
Placebo
n=60 participants at risk
The oral placebo (sugar pill) will be distributed in 500mg caplets. Patients will take 8 caplets per day.
Placebo: Placebo sugar pill 500mg caplet
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.7%
4/60 • Number of events 4 • 78 weeks
Adverse events information was reported by the participant or informant without a specific scale being administered.
|
3.3%
2/60 • Number of events 2 • 78 weeks
Adverse events information was reported by the participant or informant without a specific scale being administered.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
3.3%
2/60 • Number of events 2 • 78 weeks
Adverse events information was reported by the participant or informant without a specific scale being administered.
|
3.3%
2/60 • Number of events 2 • 78 weeks
Adverse events information was reported by the participant or informant without a specific scale being administered.
|
|
Nervous system disorders
Dizziness
|
3.3%
2/60 • Number of events 2 • 78 weeks
Adverse events information was reported by the participant or informant without a specific scale being administered.
|
1.7%
1/60 • Number of events 1 • 78 weeks
Adverse events information was reported by the participant or informant without a specific scale being administered.
|
|
Cardiac disorders
Cardiovascular
|
3.3%
2/60 • Number of events 2 • 78 weeks
Adverse events information was reported by the participant or informant without a specific scale being administered.
|
3.3%
2/60 • Number of events 2 • 78 weeks
Adverse events information was reported by the participant or informant without a specific scale being administered.
|
|
Musculoskeletal and connective tissue disorders
Fall
|
1.7%
1/60 • Number of events 1 • 78 weeks
Adverse events information was reported by the participant or informant without a specific scale being administered.
|
1.7%
1/60 • Number of events 1 • 78 weeks
Adverse events information was reported by the participant or informant without a specific scale being administered.
|
Additional Information
Dr. Davangere P Devanand
Columbia University Irving Medical Center
Phone: 646-774-8658
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place